AnesthesiaANDES platformNCT06452147
Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial)
A study testing Nerve block, Standard anesthesia care and Bupivacaine liposome in people with Anesthesia and Hip Fractures, run by Second Affiliated Hospital of Wenzhou Medical University at 13 sites in China.
Trial summary
The ANDES Platform Trial is a pragmatic, multicenter, adaptive randomized controlled platform trial in patients aged 65 years or older undergoing surgery for hip fracture. The trial evaluates whether enhanced anesthesia techniques reduce perioperative neurocognitive disorders compared with standard anesthesia care. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Hip Fractures, Dementia
- What is being tested?
- Nerve block, Standard anesthesia care and Bupivacaine liposome
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,860 participants
- Where
- 13 sitesChina
- Study dates
- 19 Jun 2024to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 years and older.
- Patients with unilateral hip fracture (including femoral neck, femoral head, intertrochanteric and subtrochanteric fractures) are scheduled for surgical treatment.
- American Society of Anesthesiologists (ASA) physical status IV or below.
- The patients or family members provide written informed consent.
- Additional inclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.
Who cannot join
- Patients with multiple trauma or fractures (excluding trauma that the researcher judges will not affect the patient's overall recovery, such as simple spinal compression fractures, mild soft tissue contusions, fractures of hands and feet, etc.);
- Two or more anesthetic surgeries are required.
- Patients with an obvious history of head trauma (such as loss of consciousness for more than 5 minutes, post-traumatic amnesia, etc.);
- Patients who the researcher believes are unable to complete the assessment of primary outcome;
- Additional exclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.
- Additional exclusion criteria for the nerve block randomization:
Show all 14Show fewer
- Contraindications to nerve block, including allergy to local anesthetics, other contraindications specified in the applicable prescribing information, infection at the puncture site, or refusal to receive nerve block;
- The investigator considers the participant unsuitable for nerve block because of conditions such as a history of severe peripheral neuropathy or severe coagulation dysfunction;
- Receipt of nerve block before randomization during the current hospitalization.
- Additional exclusion criteria for the intravenous lidocaine randomization:
- Allergy to lidocaine;
- Severe hepatic impairment or renal insufficiency for which the investigator considers the participant unsuitable for enrollment.
- Eligibility Criteria for nonsurgical cognitive control participants:
- A nonsurgical cognitive control cohort may be recruited from emergency departments, outpatient clinics, inpatient wards, or the community for standardization of neurocognitive assessments. These participants will be matched as far as possible to surgical participants by age and education level. Except for criteria related to hip fracture surgery and trial interventions, the same general inclusion and exclusion criteria will apply. Nonsurgical cognitive control participants must not undergo surgery or anesthesia during the observation period; participants who undergo surgery during follow-up will be excluded from the nonsurgical cognitive control cohort.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Enrolling by invitation
Dongyang People's Hospital
Dongyang, Zhejiang
- Enrolling by invitation
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
- Recruiting
Jinhua Municipal Central Hospital
Jinhua, Zhejiang
Yuanliang Chen, MD, chenyl1186@163.com
- Recruiting
Lishui Central Hospital, the Fifth Hospital Affiliated to Wenzhou Medical University
Lishui, Zhejiang
Chuanguang Wang, MD, wcg0033@wmu.edu.cn
- Recruiting
Lishui People's Hospital
Lishui, Zhejiang
Jimin Wu, MD, wujimin2022@163.com
- Recruiting
Ningbo No.2 Hospital
Ningbo, Zhejiang
Junping Chen, MD, 13858222873@163.com
- Recruiting
Ningbo No.6 Hospital
Ningbo, Zhejiang
Liyong Yuan, MD, ylysgl@hotmail.com
- Recruiting
Quzhou People's Hospital
Quzhou, Zhejiang
Xiangyu Fang, MD, 15811076@qq.com
- Enrolling by invitation
Taizhou Central Hospital
Taizhou, Zhejiang
- Enrolling by invitation
Zhejiang Taizhou Hospital
Taizhou, Zhejiang
- Recruiting
The First People's Hospital of Wenling
Wenling, Zhejiang
Yanguo Zheng, MD, zygm15@126.com
- Enrolling by invitation
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
- Recruiting
The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Ting Li, PhD, 13587876896, liting1021@aliyun.com
Ting Li, PhD
About this study
Official title: Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial): A Pragmatic Multi-arm, Adaptive, Open Label, Multicenter Randomized Controlled Platform Trial to Assess the Effect of Different Enhanced Anesthesia Technique in Perioperative Neurocognitive Function, as Compared to Standard Anesthesia Care in the Elderly Patients Undergoing Hip Fracture
The ANDES Platform Trial is a pragmatic, multicenter, adaptive randomized controlled platform trial in patients aged 65 years or older undergoing surgery for hip fracture. The trial evaluates whether enhanced anesthesia techniques reduce perioperative neurocognitive disorders compared with standard anesthesia care.
The platform includes two randomization processes. In the first randomization, eligible participants are assigned to an active platform intervention-currently a preoperative regional nerve block or perioperative intravenous lidocaine infusion-or to a shared standard-anesthesia control. Participants for whom general anesthesia is planned may also enter a second, nested randomization and are assigned in a fixed 1:1 ratio to total intravenous anesthesia or volatile inhalational anesthesia, regardless of whether they participate in the first randomization.
A non-surgical cognitive control cohort is included to characterize changes in cognitive test performance over time without exposure to surgery or study interventions. The Data Monitoring Committee reviews accumulating trial data and makes recommendations to the Trial Steering Committee, which determines whether platform interventions should continue, be modified, advance, or stop.
Read the detailed description
The ANDES Platform Trial is a pragmatic, multicenter, adaptive platform trial designed to evaluate anesthesia strategies for reducing perioperative neurocognitive disorders in older patients undergoing hip fracture surgery.
The trial includes two related randomization processes.
In the first randomization, participants who meet the eligibility criteria for a specific platform intervention are randomly assigned to that intervention or to shared standard anesthesia care. The current platform interventions include preoperative regional nerve block and perioperative intravenous lidocaine infusion. Each intervention is compared with control participants who were eligible for randomization to that intervention.
Participants for whom the responsible anesthesiologist plans to use general anesthesia may enter a second, nested randomization, irrespective of their participation in the first randomization. These participants are assigned in a fixed 1:1 ratio to one of two anesthetic-maintenance strategies: total intravenous anesthesia, for which propofol-based maintenance is recommended, or volatile anesthesia, for which maintenance mainly with sevoflurane or isoflurane is recommended following intravenous induction.
Patients and treating clinicians are not blinded because of the nature of the interventions. Where implemented as specified in the protocol, outcome assessors remain unaware of treatment allocation, and statistical analyses are conducted using blinded treatment codes.
The study also includes a non-surgical cognitive control cohort. Members of this cohort do not undergo study randomization and do not receive any trial intervention. The cohort is used to help characterize changes associated with repeated cognitive testing and changes in cognition over time in the absence of surgery.
The platform allows interventions to be introduced, modified, advanced, or discontinued in accordance with the master protocol and applicable intervention-specific subprotocols. Accumulating safety and effectiveness data are reviewed by the independent Data Monitoring Committee. The committee makes recommendations to the Trial Steering Committee, which is responsible for platform decisions in accordance with the prespecified adaptive decision framework.
- Conditions
- Anesthesia, Hip Fractures, Dementia, Cognitive Impairment, Cognitive Decline
- Being tested
- Nerve block, Standard anesthesia care, Bupivacaine liposome, Regular local anesthetic, Intravenous infusion of lidocaine
- Medical subject headings
- Hip Fractures, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve blockProcedure or surgery
Participants receive a preoperative regional nerve block as soon as possible after randomization. Ultrasound guidance is recommended, and fascia iliaca block is the recommended block technique.
Standard anesthesia careProcedure or surgery
Standard anesthesia care consists of routine general or regional anesthesia according to usual practice at each study center. Participants randomized to the shared control group do not receive protocol-specified trial interventions unless otherwise required by the Trial Steering Committee. Changes to standard anesthesia care are made in accordance with the prespecified adaptive decision framework. The independent Data Monitoring Committee reviews accumulating data and makes recommendations to the Trial Steering Committee, which makes the final platform decisions.
Bupivacaine liposomeDrug
For participants randomized to the nerve block group, 1.33% bupivacaine liposome is recommended as a long-acting local anesthetic, with a maximum dose not exceeding 133 mg, to maintain the continuity of the nerve block effect.
Regular local anestheticDrug
For participants randomized to the nerve block group, regular local anesthetic, such as bupivacaine or ropivacaine, may be used with continuous electronic analgesic pump infusion or multiple single injections to maintain the continuity of the nerve block effect.
Intravenous infusion of lidocaineDrug
Participants randomized to the lidocaine group receive ECG monitoring, oxygen saturation monitoring, blood pressure monitoring, and an open intravenous route on the morning of surgery. It is recommended to start the infusion of lidocaine as soon as possible in the ward. A portable electronic infusion pump is recommended for drug delivery. The loading dose is 1 mg/kg, and the maintenance dose range is 1 to 2 mg/kg/h. The specific dose is determined by the anesthesiologist according to the patient's condition. The infusion ends when the patient leaves the post-anesthesia care unit after surgery, and the infusion time and total amount are recorded. Intravenous infusion of lidocaine should be administered under ECG monitoring.
Total intravenous anesthesia maintenanceProcedure or surgery
Among participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to total intravenous anesthesia maintenance in a 1:1 ratio. Total intravenous anesthesia maintenance is recommended to be mainly propofol-based, and analgesics such as remifentanil or fentanyl are recommended.
Volatile anesthesia maintenanceProcedure or surgery
Among participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to volatile anesthesia maintenance in a 1:1 ratio. Following intravenous induction, anesthesia maintenance mainly with sevoflurane or isoflurane is recommended.
| Study group | Role | What they receive |
|---|---|---|
| Nerve block | Experimental | Participants receive standard anesthesia care plus preoperative regional nerve block, as described in sub-trial protocol 1. Participants in this arm who are planned to undergo general anesthesia may also enter the second nested randomization and be assigned in a 1:1 ratio to total intravenous anesthesia or volatile anesthesia maintenance. Receives: Procedure: Nerve block; Procedure: Standard anesthesia care; Drug: Bupivacaine liposome; Drug: Regular local anesthetic; Procedure: Total intravenous anesthesia maintenance; Procedure: Volatile anesthesia maintenance |
| Intravenous infusion of lidocaine | Experimental | Participants receive standard anesthesia care plus perioperative intravenous lidocaine infusion, as described in sub-trial protocol 2. Participants in this arm who are planned to undergo general anesthesia may also enter the second nested randomization and be assigned in a 1:1 ratio to total intravenous anesthesia or volatile anesthesia maintenance. Receives: Procedure: Standard anesthesia care; Drug: Intravenous infusion of lidocaine; Procedure: Total intravenous anesthesia maintenance; Procedure: Volatile anesthesia maintenance |
| Shared standard anesthesia care | Active comparator | Participants receive standard anesthesia care. Participants for whom general anesthesia is planned may also enter the second nested randomization and be assigned in a fixed 1:1 ratio to total intravenous anesthesia maintenance or volatile anesthesia maintenance. Receives: Procedure: Standard anesthesia care; Procedure: Total intravenous anesthesia maintenance; Procedure: Volatile anesthesia maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days
Neurocognitive Disorders includes:
- Postoperative delirium (POD) was mesaured by 3D-CAM;
- Neurocognitive decline was mesaured within 7 postoperative days by: Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), and neuropsychological tests containing 5 cognitive domains (1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, and active report of patients or family members).
Neurocognitive function is assessed at screening, postoperative day 3, and postoperative day 7. If discharge occurs on postoperative day 5 or 6, the final assessment is performed on the day of discharge; if discharge occurs on postoperative day 4, no repeat cognitive assessment is performed. A participant with postoperative delirium and/or postoperative neurocognitive decline is classified as positive for the primary outcome.
Measured: during the first 7 postoperative days
Secondary outcomes (17)
Subtypes, severity, and duration of delirium
Using CAM-S, and in units of days from the onset of delirium symptoms to the disappearance of symptoms or when the patient is discharged.
Measured: during the first 7 postoperative days
Neurocognitive decline in postoperative 7 days
Neurocognitive decline was mesaured by: Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA), or neuropsychological tests containing 5 cognitive domains (1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, or active report of patients or family members.
Measured: during the first 7 postoperative days
Delayed neurocognitive recovery during 30 postoperative days
This was mesaured by: Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA), or neuropsychological tests containing 5 cognitive domains(1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, or active report of patients or family members.
Measured: Postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, and postoperative day 30 ± 7 days.
Hospital Anxiety and Depression Scale (HADs)
Measured: At screening, postoperative day 5 ± 2 days, postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, postoperative day 30 ± 7 days, and postoperative month 12 ± 1 month.
Acute pain before and after surgery
Using Visual Analogue Scale (VAS)
Measured: Before surgery and on postoperative days 1, 2, and 3.
Length of hospitalization
Measured: days from admission to discharge, an average of 7 days
Incidence of important intraoperative adverse events requiring treatment
Important intraoperative adverse events are defined as adverse events requiring treatment.
Measured: During anesthesia on the day of surgery.
Complications (except cognitive impairment)
including pulmonary infection, myocardial infarction, renal failure, gastrointestinal obstruction, etc.
Measured: during postoperation 30 days
In-hospital and 30-day mortality
Measured: During hospitalization and within 30 days after surgery.
Days at home up to 30 days after surgery (DAH30)
Measured: up to 30 days after surgery
Score of EuroQol Five Dimensions Questionnaire (EQ-5D)
Quality of life will be assessed using the EuroQol Five Dimensions Questionnaire (EQ-5D). Prefracture quality of life will be assessed retrospectively for the week before fracture.
Measured: 1 week before fracture (retrospective assessment), and 1, 3, 6, 9, and 12 months after surgery.
Incidence of postoperative Neurocognitive Disorders (NCD)
Postoperative neurocognitive disorder will be determined as a binary outcome according to the prespecified neurocognitive assessment framework. Cognitive assessments, including the Mini-Mental State Examination, Montreal Cognitive Assessment, multidomain neuropsychological tests, and patient- or caregiver-reported cognitive change, will be integrated according to the prespecified criteria to determine whether postoperative neurocognitive disorder is present. The reported outcome is the proportion of participants with postoperative neurocognitive disorder.
Measured: Up to 12 months after surgery.
Severity of postoperative Neurocognitive Disorders (NCD)
Measured: At 12 months after surgery
Type of postoperative Neurocognitive Disorders (NCD)
Using Hachinski Ischemic Scale (HIS) combined with clinical symptoms and auxiliary examination to mesaure the type of postoperative NCD. HIS ≥7 was considered as vascular cognitive impairment.
Measured: within 1 year after surgery (long-term)
Instrumental Activities of Daily Living (IADL)
Measured: At screening for the week before fracture, postoperative day 5 ± 2 days, postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, postoperative day 30 ± 7 days, and postoperative months 3, 6, 9, and 12.
1-year all-cause mortality
Measured: 1-year after surgery
Health economic outcomes
Health economic outcomes include direct medical costs, direct nonmedical costs, and indirect costs. Direct medical costs include anesthesia and related costs, surgical treatment costs, medication and biological product costs, diagnosis-related costs, supportive treatment costs, rehabilitation costs, blood and blood product costs, and consumable material costs. Direct nonmedical costs include paid caregiver costs, transportation costs, and accommodation costs related to medical care. Indirect costs mainly include productivity losses of family members or unpaid caregivers due to accompanying or caring for the participant.
Measured: During hospitalization; from hospital discharge to the 1-month follow-up; and for each interval from the previous follow-up visit to the 3-, 6-, 9-, and 12-month follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start19 Jun 2024
- Primary completion30 Jul 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,860 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo No.2 Hospital, Ningbo No.6 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou Hospital, Affiliated Wenling Hospital of Wenzhou Medical University, Lishui Country People's Hospital, The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, People's Hospital of Quzhou
- Responsible party
- Sponsor
- Investigators
- Ting Li, MD, PhD, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452147
- Sponsor's protocol ID
- SAHoWMU-CR2024-03-112
- Acronym
- ANDES platform
- Status last verified
- Sep 2026
- First submitted
- 28 May 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Within 1 year after study completion, study data and related documentation will be made available upon request to the principal investigator or data coordinating center. The documentation will include annotated case report forms, descriptions of the structure, variables, and content of each dataset, the final protocol, study procedures, data collection forms, descriptions of variable recoding, and lists and links to major publications. Key datasets will be archived as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial): A Pragmatic Multi-arm, Adaptive, Open Label, Multicenter Randomized Controlled Platform Trial to Assess the Effect of Different Enhanced Anesthesia Technique in Perioperative Neurocognitive Function, as Compared to Standard Anesthesia Care in the Elderly Patients Undergoing Hip Fracture
- ClinicalTrials.gov ID
- NCT06452147
- Acronym / sponsor ID
- ANDES platform / SAHoWMU-CR2024-03-112
- Conditions
- Anesthesia, Hip Fractures, Dementia, Cognitive Impairment, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,860 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo No.2 Hospital, Ningbo No.6 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou Hospital, Affiliated Wenling Hospital of Wenzhou Medical University, Lishui Country People's Hospital, The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, People's Hospital of Quzhou
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ANDES Platform Trial is a pragmatic, multicenter, adaptive randomized controlled platform trial in patients aged 65 years or older undergoing surgery for hip fracture. The trial evaluates whether enhanced anesthesia techniques reduce perioperative neurocognitive disorders compared with standard anesthesia care.
The platform includes two randomization processes. In the first randomization, eligible participants are assigned to an active platform intervention-currently a preoperative regional nerve block or perioperative intravenous lidocaine infusion-or to a shared standard-anesthesia control. Participants for whom general anesthesia is planned may also enter a second, nested randomization and are assigned in a fixed 1:1 ratio to total intravenous anesthesia or volatile inhalational anesthesia, regardless of whether they participate in the first randomization.
A non-surgical cognitive control cohort is included to characterize changes in cognitive test performance over time without exposure to surgery or study interventions. The Data Monitoring Committee reviews accumulating trial data and makes recommendations to the Trial Steering Committee, which determines whether platform interventions should continue, be modified, advance, or stop.
Detailed description
The ANDES Platform Trial is a pragmatic, multicenter, adaptive platform trial designed to evaluate anesthesia strategies for reducing perioperative neurocognitive disorders in older patients undergoing hip fracture surgery.
The trial includes two related randomization processes.
In the first randomization, participants who meet the eligibility criteria for a specific platform intervention are randomly assigned to that intervention or to shared standard anesthesia care. The current platform interventions include preoperative regional nerve block and perioperative intravenous lidocaine infusion. Each intervention is compared with control participants who were eligible for randomization to that intervention.
Participants for whom the responsible anesthesiologist plans to use general anesthesia may enter a second, nested randomization, irrespective of their participation in the first randomization. These participants are assigned in a fixed 1:1 ratio to one of two anesthetic-maintenance strategies: total intravenous anesthesia, for which propofol-based maintenance is recommended, or volatile anesthesia, for which maintenance mainly with sevoflurane or isoflurane is recommended following intravenous induction.
Patients and treating clinicians are not blinded because of the nature of the interventions. Where implemented as specified in the protocol, outcome assessors remain unaware of treatment allocation, and statistical analyses are conducted using blinded treatment codes.
The study also includes a non-surgical cognitive control cohort. Members of this cohort do not undergo study randomization and do not receive any trial intervention. The cohort is used to help characterize changes associated with repeated cognitive testing and changes in cognition over time in the absence of surgery.
The platform allows interventions to be introduced, modified, advanced, or discontinued in accordance with the master protocol and applicable intervention-specific subprotocols. Accumulating safety and effectiveness data are reviewed by the independent Data Monitoring Committee. The committee makes recommendations to the Trial Steering Committee, which is responsible for platform decisions in accordance with the prespecified adaptive decision framework.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nerve block | Experimental | Procedure: Nerve block, Procedure: Standard anesthesia care, Drug: Bupivacaine liposome, Drug: Regular local anesthetic, Procedure: Total intravenous anesthesia maintenance, Procedure: Volatile anesthesia maintenanceParticipants receive standard anesthesia care plus preoperative regional nerve block, as described in sub-trial protocol 1. Participants in this arm who are planned to undergo general anesthesia may also enter the second nested randomization and be assigned in a 1:1 ratio to total intravenous anesthesia or volatile anesthesia maintenance. |
| Intravenous infusion of lidocaine | Experimental | Procedure: Standard anesthesia care, Drug: Intravenous infusion of lidocaine, Procedure: Total intravenous anesthesia maintenance, Procedure: Volatile anesthesia maintenanceParticipants receive standard anesthesia care plus perioperative intravenous lidocaine infusion, as described in sub-trial protocol 2. Participants in this arm who are planned to undergo general anesthesia may also enter the second nested randomization and be assigned in a 1:1 ratio to total intravenous anesthesia or volatile anesthesia maintenance. |
| Shared standard anesthesia care | Active comparator | Procedure: Standard anesthesia care, Procedure: Total intravenous anesthesia maintenance, Procedure: Volatile anesthesia maintenanceParticipants receive standard anesthesia care. Participants for whom general anesthesia is planned may also enter the second nested randomization and be assigned in a fixed 1:1 ratio to total intravenous anesthesia maintenance or volatile anesthesia maintenance. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged 65 years and older.
- Patients with unilateral hip fracture (including femoral neck, femoral head, intertrochanteric and subtrochanteric fractures) are scheduled for surgical treatment.
- American Society of Anesthesiologists (ASA) physical status IV or below.
- The patients or family members provide written informed consent.
- Additional inclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.
Key exclusion criteria (14 listed)
- Patients with multiple trauma or fractures (excluding trauma that the researcher judges will not affect the patient's overall recovery, such as simple spinal compression fractures, mild soft tissue contusions, fractures of hands and feet, etc.);
- Two or more anesthetic surgeries are required.
- Patients with an obvious history of head trauma (such as loss of consciousness for more than 5 minutes, post-traumatic amnesia, etc.);
- Patients who the researcher believes are unable to complete the assessment of primary outcome;
- Additional exclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve blockParticipants receive a preoperative regional nerve block as soon as possible after randomization. Ultrasound guidance is recommended, and fascia iliaca block is the recommended block technique. | Procedure or surgery | Nerve block |
| Standard anesthesia careStandard anesthesia care consists of routine general or regional anesthesia according to usual practice at each study center. Participants randomized to the shared control group do not receive protocol-specified trial interventions unless otherwise required by the Trial Steering Committee. Changes to standard anesthesia care are made in accordance with the prespecified adaptive decision framework. The independent Data Monitoring Committee reviews accumulating data and makes recommendations to the Trial Steering Committee, which makes the final platform decisions. | Procedure or surgery | Intravenous infusion of lidocaine, Nerve block, Shared standard anesthesia care |
| Bupivacaine liposomeFor participants randomized to the nerve block group, 1.33% bupivacaine liposome is recommended as a long-acting local anesthetic, with a maximum dose not exceeding 133 mg, to maintain the continuity of the nerve block effect. | Drug | Nerve block |
| Regular local anestheticFor participants randomized to the nerve block group, regular local anesthetic, such as bupivacaine or ropivacaine, may be used with continuous electronic analgesic pump infusion or multiple single injections to maintain the continuity of the nerve block effect. | Drug | Nerve block |
| Intravenous infusion of lidocaineParticipants randomized to the lidocaine group receive ECG monitoring, oxygen saturation monitoring, blood pressure monitoring, and an open intravenous route on the morning of surgery. It is recommended to start the infusion of lidocaine as soon as possible in the ward. A portable electronic infusion pump is recommended for drug delivery. The loading dose is 1 mg/kg, and the maintenance dose range is 1 to 2 mg/kg/h. The specific dose is determined by the anesthesiologist according to the patient's condition. The infusion ends when the patient leaves the post-anesthesia care unit after surgery, and the infusion time and total amount are recorded. Intravenous infusion of lidocaine should be administered under ECG monitoring. | Drug | Intravenous infusion of lidocaine |
| Total intravenous anesthesia maintenanceAmong participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to total intravenous anesthesia maintenance in a 1:1 ratio. Total intravenous anesthesia maintenance is recommended to be mainly propofol-based, and analgesics such as remifentanil or fentanyl are recommended. | Procedure or surgery | Intravenous infusion of lidocaine, Nerve block, Shared standard anesthesia care |
| Volatile anesthesia maintenanceAmong participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to volatile anesthesia maintenance in a 1:1 ratio. Following intravenous induction, anesthesia maintenance mainly with sevoflurane or isoflurane is recommended. | Procedure or surgery | Intravenous infusion of lidocaine, Nerve block, Shared standard anesthesia care |
Primary outcome
Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days
Time frame: during the first 7 postoperative days
Neurocognitive Disorders includes: 1. Postoperative delirium (POD) was mesaured by 3D-CAM; 2. Neurocognitive decline was mesaured within 7 postoperative days by: Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), and neuropsychological tests containing 5 cognitive domains (1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, and active report of patients or family members). Neurocognitive function is assessed at screening, postoperative day 3, and postoperative day 7. If discharge occurs on postoperative day 5 or 6, the final assessment is performed on the day of discharge; if discharge occurs on postoperative day 4, no repeat cognitive assessment is performed. A participant with postoperative delirium and/or postoperative neurocognitive decline is classified as positive for the primary outcome.
17 secondary outcomes
Subtypes, severity, and duration of delirium
Time frame: during the first 7 postoperative days
Neurocognitive decline in postoperative 7 days
Time frame: during the first 7 postoperative days
Delayed neurocognitive recovery during 30 postoperative days
Time frame: Postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, and postoperative day 30 ± 7 days.
Hospital Anxiety and Depression Scale (HADs)
Time frame: At screening, postoperative day 5 ± 2 days, postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, postoperative day 30 ± 7 days, and postoperative month 12 ± 1 month.
Acute pain before and after surgery
Time frame: Before surgery and on postoperative days 1, 2, and 3.
Length of hospitalization
Time frame: days from admission to discharge, an average of 7 days
Incidence of important intraoperative adverse events requiring treatment
Time frame: During anesthesia on the day of surgery.
Complications (except cognitive impairment)
Time frame: during postoperation 30 days
In-hospital and 30-day mortality
Time frame: During hospitalization and within 30 days after surgery.
Days at home up to 30 days after surgery (DAH30)
Time frame: up to 30 days after surgery
Score of EuroQol Five Dimensions Questionnaire (EQ-5D)
Time frame: 1 week before fracture (retrospective assessment), and 1, 3, 6, 9, and 12 months after surgery.
Incidence of postoperative Neurocognitive Disorders (NCD)
Time frame: Up to 12 months after surgery.
Severity of postoperative Neurocognitive Disorders (NCD)
Time frame: At 12 months after surgery
Type of postoperative Neurocognitive Disorders (NCD)
Time frame: within 1 year after surgery (long-term)
Instrumental Activities of Daily Living (IADL)
Time frame: At screening for the week before fracture, postoperative day 5 ± 2 days, postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, postoperative day 30 ± 7 days, and postoperative months 3, 6, 9, and 12.
1-year all-cause mortality
Time frame: 1-year after surgery
Health economic outcomes
Time frame: During hospitalization; from hospital discharge to the 1-month follow-up; and for each interval from the previous follow-up visit to the 3-, 6-, 9-, and 12-month follow-up visits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. Within 1 year after study completion, study data and related documentation will be made available upon request to the principal investigator or data coordinating center. The documentation will include annotated case report forms, descriptions of the structure, variables, and content of each dataset, the final protocol, study procedures, data collection forms, descriptions of variable recoding, and lists and links to major publications. Key datasets will be archived as appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ting Li, MD, PhD principal investigator
Second Affiliated Hospital of Wenzhou Medical University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve block, Standard anesthesia care and Bupivacaine liposome in people with Anesthesia and Hip Fractures, run by Second Affiliated Hospital of Wenzhou Medical University at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Li, MD, PhD (13587876896, liting1021@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days (time frame: during the first 7 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.