Delirium - PostoperativePhase 4NCT06958393
Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery
A Phase 4 study testing Dexmedetomidine, Esketamine and Esmolol in people with Delirium - Postoperative and Opioid-Free Anaesthesia, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Background Postoperative delirium (POD) is a common acute and transient form of brain dysfunction in elderly patients following surgery that can lead to serious adverse clinical outcomes and even death. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium - Postoperative, Opioid-Free Anaesthesia
- What is being tested?
- Dexmedetomidine, Esketamine and Esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 12 May 2026
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥ 65 years
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Scheduled for elective gastrointestinal surgery under general anaesthesia
- Body mass index (BMI) between 18.0 and 30.0 kg/m²
Who cannot join
- Refusal to undergo surgery
- Emergency surgery
- Language impairment or severe hearing or visual deficits that hinder effective communication with research or surgical staff
- History of neurological or psychiatric disorders, including Alzheimer's disease (AD), other forms of dementia, stroke, or psychosis
- Long-term use of psychotropic medications (e.g., clozapine, risperidone, olanzapine, haloperidol, chlorpromazine)
- Cardiac or craniocerebral surgery within the past year
Show all 9Show fewer
- Participation in other interventional clinical studies within the past 3 months
- Preoperative cognitive impairment defined as a modified Telephone Interview for Cognitive Status (TICS-M) score ≤ 27
- Patients will only be enrolled once, even if a subsequent surgery related to the primary procedure is performed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
Yongtao Sun, +8618660795201
About this study
Official title: Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery: a Single-centre, Prospective, Randomized Controlled Trial
Background Postoperative delirium (POD) is a common acute and transient form of brain dysfunction in elderly patients following surgery that can lead to serious adverse clinical outcomes and even death. Although existing studies have preliminarily investigated the effects of opioid-free anaesthesia (OFA) on POD, high-quality evidence on these effects for elderly patients undergoing gastrointestinal surgery remains limited. This study aims to investigate the effects of OFA on the development of POD in elderly patients following gastrointestinal surgery.
Methods and analysis:
Read more
This single-centre, prospective, randomized controlled trial will be conducted at the First Affiliated Hospital of Shandong First Medical University, China. A total of 406 patients aged 65 years or older who are scheduled for elective gastrointestinal surgery will be randomly allocated to receive either opioid-free anaesthesia (OFA; dexmedetomidine, esmolol, and esketamine) or conventional opioid-based anaesthesia (OBA). The primary outcome is the incidence of POD 7 days after surgery. The secondary outcomes are all-cause mortality within 30 days after surgery, intraoperative haemodynamic changes, the 15-item quality of recovery (QoR-15) scores at 24 h, 48 h, and 72 h after surgery, complications during postoperative hospitalization, pain numerical rating scale (NRS) score at 72 h after surgery, incidence of nausea and vomiting at 72 h after surgery, morphine milligram equivalent for analgesics at 72 h after surgery, duration of anaesthesia (from induction to discontinuation), duration of surgery (from skin incision to the last suture), duration of post-anaesthesia care unit (PACU) stay, and length of hospital stay.
Discussion:
The results of this study may shed light on the effects of OFA on POD in elderly patients undergoing gastrointestinal surgery. The study is designed on the basis of the following key hypothesis: the use of opioid drugs for anaesthesia may increase the risk of POD through mechanisms such as blood-brain barrier destruction, neuroinflammatory responses, and central nervous system depression. Through the single-centre and prospective design of this randomized controlled trial, this study will directly analyse differences in the effects of OFA and conventional OBA on the incidence of POD, haemodynamic stability and long-term cognitive function in elderly patients.
gastrointestinal surgery.
- Conditions
- Delirium - Postoperative, Opioid-Free Anaesthesia
- Being tested
- Dexmedetomidine, Esketamine, Esmolol, Sufentanil, Remifentanil
- Keywords
- elderly patients, opioid-free anaesthesia, postoperative delirium, gastrointestinal surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Continuous infusion at 0.5-1.0 μg/kg/h during surgery
EsketamineDrug
Induction dose 0.3-0.5 mg/kg; maintenance 0.2-0.5 mg/kg/h; 0.02 mg/kg at closure; PCIA: 1.5 mg/kg in 100 mL saline
EsmololDrug
Maintenance 20-100 μg/kg/min during surgery
SufentanilDrug
0.3-0.5 μg/kg induction; 0.15 μg/kg at closure; 2 μg/kg in 100 mL for PCIA
RemifentanilDrug
0.2-1.0 μg/kg/min maintenance
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Based Anaesthesia (OBA) Group | Active comparator | Patients receive conventional opioid-based general anaesthesia, including sufentanil and remifentanil during surgery and sufentanil-based patient-controlled intravenous analgesia (PCIA) postoperatively. Receives: Drug: Sufentanil; Drug: Remifentanil |
| Opioid-Free Anaesthesia (OFA) Group | Experimental | Patients receive opioid-free anaesthesia using a standardized multimodal regimen (dexmedetomidine, esmolol, and esketamine) for intraoperative management and esketamine-based PCIA postoperatively. Receives: Drug: Dexmedetomidine; Drug: Esketamine; Drug: Esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POD at discharge or within 7 days after surgery.
The proportion of participants who develop postoperative delirium, assessed either at discharge or within 7 days after surgery. Diagnosis of POD will be based on standardized clinical assessment tools (e.g., Confusion Assessment Method, CAM).Results will be reported as the percentage of participants (%).
Measured: Discharge or within 7 days after surgery
Secondary outcomes (1)
30-day All-Cause Mortality
The proportion of participants who die from any cause during the initial hospitalization or within 30 calendar days following the index surgical procedure.The proportion of participants who die from any cause during the initial hospitalization or within 30 calendar days following the index surgical procedure. Results will be reported as the percentage of participants (%).
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start20 May 2025 (estimated)
- Primary completion5 Jan 2026 (estimated)
- Study completion12 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongtao Sun, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958393
- Sponsor's protocol ID
- opioid-free anaesthesia
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Du Y, Liu M, Yang X, Wu J, Gao X, Liu Q, Chen L, Sun X, Zhang M, Sun Y. Effect of opioid-free anaesthesia on postoperative delirium in elderly patients undergoing gastrointestinal surgery: study protocol for a single-centre, prospective, randomized controlled trial. BMC Geriatr. 2025 Jul 28;25(1):554. doi: 10.1186/s12877-025-06145-8.
PubMed 40721742
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery: a Single-centre, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06958393
- Acronym / sponsor ID
- opioid-free anaesthesia
- Conditions
- Delirium - Postoperative, Opioid-Free Anaesthesia
- Keywords
- elderly patients, opioid-free anaesthesia, postoperative delirium, gastrointestinal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 5 Jan 2026 (estimated)
- Study completion
- 12 May 2026 (estimated)
- First posted
- 6 May 2025 (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.
Background Postoperative delirium (POD) is a common acute and transient form of brain dysfunction in elderly patients following surgery that can lead to serious adverse clinical outcomes and even death. Although existing studies have preliminarily investigated the effects of opioid-free anaesthesia (OFA) on POD, high-quality evidence on these effects for elderly patients undergoing gastrointestinal surgery remains limited. This study aims to investigate the effects of OFA on the development of POD in elderly patients following gastrointestinal surgery.
Methods and analysis:
This single-centre, prospective, randomized controlled trial will be conducted at the First Affiliated Hospital of Shandong First Medical University, China. A total of 406 patients aged 65 years or older who are scheduled for elective gastrointestinal surgery will be randomly allocated to receive either opioid-free anaesthesia (OFA; dexmedetomidine, esmolol, and esketamine) or conventional opioid-based anaesthesia (OBA). The primary outcome is the incidence of POD 7 days after surgery. The secondary outcomes are all-cause mortality within 30 days after surgery, intraoperative haemodynamic changes, the 15-item quality of recovery (QoR-15) scores at 24 h, 48 h, and 72 h after surgery, complications during postoperative hospitalization, pain numerical rating scale (NRS) score at 72 h after surgery, incidence of nausea and vomiting at 72 h after surgery, morphine milligram equivalent for analgesics at 72 h after surgery, duration of anaesthesia (from induction to discontinuation), duration of surgery (from skin incision to the last suture), duration of post-anaesthesia care unit (PACU) stay, and length of hospital stay.
Discussion:
The results of this study may shed light on the effects of OFA on POD in elderly patients undergoing gastrointestinal surgery. The study is designed on the basis of the following key hypothesis: the use of opioid drugs for anaesthesia may increase the risk of POD through mechanisms such as blood-brain barrier destruction, neuroinflammatory responses, and central nervous system depression. Through the single-centre and prospective design of this randomized controlled trial, this study will directly analyse differences in the effects of OFA and conventional OBA on the incidence of POD, haemodynamic stability and long-term cognitive function in elderly patients.
gastrointestinal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-Based Anaesthesia (OBA) Group | Active comparator | Drug: Sufentanil, Drug: RemifentanilPatients receive conventional opioid-based general anaesthesia, including sufentanil and remifentanil during surgery and sufentanil-based patient-controlled intravenous analgesia (PCIA) postoperatively. |
| Opioid-Free Anaesthesia (OFA) Group | Experimental | Drug: Dexmedetomidine, Drug: Esketamine, Drug: EsmololPatients receive opioid-free anaesthesia using a standardized multimodal regimen (dexmedetomidine, esmolol, and esketamine) for intraoperative management and esketamine-based PCIA postoperatively. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 65 years
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Scheduled for elective gastrointestinal surgery under general anaesthesia
- Body mass index (BMI) between 18.0 and 30.0 kg/m²
Key exclusion criteria (9 listed)
- Refusal to undergo surgery
- Emergency surgery
- Language impairment or severe hearing or visual deficits that hinder effective communication with research or surgical staff
- History of neurological or psychiatric disorders, including Alzheimer's disease (AD), other forms of dementia, stroke, or psychosis
- Long-term use of psychotropic medications (e.g., clozapine, risperidone, olanzapine, haloperidol, chlorpromazine)
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 |
|---|---|---|
| DexmedetomidineContinuous infusion at 0.5-1.0 μg/kg/h during surgery | Drug | Opioid-Free Anaesthesia (OFA) Group |
| EsketamineInduction dose 0.3-0.5 mg/kg; maintenance 0.2-0.5 mg/kg/h; 0.02 mg/kg at closure; PCIA: 1.5 mg/kg in 100 mL saline | Drug | Opioid-Free Anaesthesia (OFA) Group |
| EsmololMaintenance 20-100 μg/kg/min during surgery | Drug | Opioid-Free Anaesthesia (OFA) Group |
| Sufentanil0.3-0.5 μg/kg induction; 0.15 μg/kg at closure; 2 μg/kg in 100 mL for PCIA | Drug | Opioid-Based Anaesthesia (OBA) Group |
| Remifentanil0.2-1.0 μg/kg/min maintenance | Drug | Opioid-Based Anaesthesia (OBA) Group |
Primary outcome
Incidence of POD at discharge or within 7 days after surgery.
Time frame: Discharge or within 7 days after surgery
The proportion of participants who develop postoperative delirium, assessed either at discharge or within 7 days after surgery. Diagnosis of POD will be based on standardized clinical assessment tools (e.g., Confusion Assessment Method, CAM).Results will be reported as the percentage of participants (%).
1 secondary outcome
30-day All-Cause Mortality
Time frame: Up to 30 days after surgery
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 6 May 2025.
- Derived from this study: PubMed 40721742Du Y, Liu M, Yang X, Wu J, Gao X, Liu Q, Chen L, Sun X, Zhang M, Sun Y. Effect of opioid-free anaesthesia on postoperative delirium in elderly patients undergoing gastrointestinal surgery: study protocol for a single-centre, prospective, randomized controlled trial. BMC Geriatr. 2025 Jul 28;25(1):554. doi: 10.1186/s12877-025-06145-8.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Esketamine and Esmolol in people with Delirium - Postoperative and Opioid-Free Anaesthesia, run by Qianfoshan Hospital at 1 site 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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yongtao Sun, Ph.D. in Anesthesiology (+86 18660795201, ytsun@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of POD at discharge or within 7 days after surgery. (time frame: Discharge or within 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958393, which also lists 1 linked publication.
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 6 May 2025.