Delirium in Old AgePhase 4NCT05158998
Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery
A Phase 4 study testing propofol infusion and sevoflurane inhalation in people with Delirium in Old Age and Anaesthetic, run by Qianfoshan Hospital at 2 sites in China.
Trial summary
Postoperative delirium in older adults is a common and costly complication after surgery. Propofol and sevoflurane are commonly used anesthetics to maintain sedation during spine surgery, and have different sedative and anti-inflammatory effects. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Delirium in Old Age, Anaesthetic
- What is being tested?
- propofol infusion and sevoflurane inhalation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 2 sitesChina
- Study dates
- 21 Mar 2022to 1 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Older adult
Who may be able to join
- age ≥65 years and ≤90 years;
- scheduled to undergo surgery for spinal, under general anaesthesia;
- American Society of Anesthesiology (ASA) I-III;
- agree to participate, and give signed written informed consents.
Who cannot join
- family history or history of malignant hyperthermia;
- History of propofol or sevoflurane allergy;
- demonstrated cognitive impairment on the modified Mini-Mental State Examination (score, <24of 30 or <20 of 30 if the patient's education year was less than 6 years or<17 if the patient is Illiterate);
- planned postoperative intubation or transferred to ICU;
- severe visual or auditory handicap;
- prior diagnoses of neurologic diseases or mental disorders (e.g., stroke, Parkinson's disease, dementia, schizophrenia, or depressive illness)
- take anticholinergic drugs or other drugs acting on the central nervous system for a long time before operation
- participating in other clinical studies in recent 3 months
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, 250000
wang yuelan, PH.D, 15953105780, wyldgf@163.com
- Recruiting
The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250013
Wang jihua, 13791125890, qy_wangjh@163.com
About this study
Official title: Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery: a Randomized Controlled Trial
Postoperative delirium in older adults is a common and costly complication after surgery. Propofol and sevoflurane are commonly used anesthetics to maintain sedation during spine surgery, and have different sedative and anti-inflammatory effects. The aim of this trial will be compare the impact of propofol versus sevoflurane on incidence of postoperative delirium in elderly patients after spine surgery.
Read the detailed description
Spine surgery is the third most common surgical procedure in older patients. With the increasing number of older patients undergoing spinal surgery, the risk of delirium after spinal surgery is currently expected to increase. The pathophysiological mechanisms of delirium remain poorly understood, leading models include neurotransmitter imbalance and neuroinflammation. Among precipitating factors, drugs (especially sedative hypnotic agents and anticholinergic agents), surgery, anesthesia, high pain levels, anemia, infections, acute illness, and acute exacerbation of chronic illness are the most commonly reported. Propofol and sevoflurane are commonly used anesthetics to maintain sedation during spinal surgery, and induce unconsciousness through different mechanisms. Meanwhile, previous studies have found that propofol and sevoflurane have different anti-inflammatory effects. Given their different sedative and anti-inflammatory effects, propofol and sevoflurane may have different effects on postoperative delirium. There are many studies to explore the effects of propofol and sevoflurane on postoperative delirium, but the conclusions are controversial. Therefore, a randomized, controlled, double-blind clinical study was designed to compare the impact of propofol and sevoflurane on delirium after spine surgery in elderly patients.
- Conditions
- Delirium in Old Age, Anaesthetic
- Being tested
- propofol infusion, sevoflurane inhalation
- Keywords
- delirium, spine surgery, anaesthetic, propofol, sevoflurane
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol infusionDrug
For patients in the propofol group, anaesthesia will be maintained with propofol infusion(target controlled infusion), of which the target concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)).Propofol infusion will be stopped at the end of surgery.
sevoflurane inhalationDrug
For patients in the sevoflurane group, anaesthesia will be maintained with sevoflurane inhalation, of which the concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Sevoflurane inhalation will be stopped at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Other | For patients in the propofol group, anaesthesia will be maintained with propofol infusion(target controlled infusion), of which the target concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Propofol infusion will be stopped at the end of surgery. Receives: Drug: propofol infusion |
| sevoflurane group | Other | For patients in the sevoflurane group, anaesthesia will be maintained with sevoflurane inhalation, of which the concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Sevoflurane inhalation will be stopped at the end of surgery. Receives: Drug: sevoflurane inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium after surgery
Delirium is assessed twice daily (8-10 AM and 6-8 PM ) with the 3 minute diagnostic interview for Confusion Assessment Method.Researchers will review all progress notes and nursing documentation for delirium diagnoses, and a thorough medical record review process using the Chart-based Delirium Identification Instrument.
Measured: Between postoperative day 1 to discharge or day 7, whichever came first
Secondary outcomes (12)
The day of postoperative delirium duration among patients who developed delirium
Date; Delirium is assessed twice daily (8-10 AM and 6-8 PM ) with the 3 minute diagnostic interview for Confusion Assessment Method
Measured: Time from first to last delirium-positive day. Between postoperative day 1 to discharge or day 7, whichever came first
The day of total delirium-positive days among patients who developed delirium
Days；Delirium is assessed twice daily (8-10 AM and 6-8 PM ) with the 3 minute diagnostic interview for Confusion Assessment Method
Measured: Between postoperative day 1 to discharge or day 7, whichever came first
The types of delirium in patients who developed delirium
Richmond Agitation- Sedation Scale will be assessed in patients who developed delirium.Patients with delirium are classified into three subtypes: hyperactive (Richmond Agitation Sedation Scale score consistently positive, from +1 to +4), hypoactive (Richmond Agitation Sedation Scale score consistently neutral or negative, from -3 to 0), and mixed.
Measured: Between postoperative day 1 to discharge or day 7, whichever came first
The intubation time in postanesthesia care unit (PACU)
minutes
Measured: From the patient transfered into PACU to tracheal extubation. Within 24 hours after surgery.
The length of stay in in postanesthesia care unit (PACU)
minutes
Measured: Within 24 hours after surgery.
Incidence of postoperative shivering in PACU
Postoperative shivering is assessed in PACU with The Crossley and Mahajan Scale. The Crossley and Mahajan Scale (0 No shivering 1 One or more of the following: piloerection, peripheral vasoconstriction, peripheralcyanosis with no other cause, but no muscle activity 2 Visible muscular activity confined to one muscle group 3 Visible muscular activity in more than one muscle 4 Gross muscular activity involving the whole body).
Measured: Within 24 hours after surgery.
Postoperative nausea and vomiting
Postoperative nausea and vomiting is assessed in PACU and postoperative days 1-3(twice daily 8-10 AM and 6-8 PM ).Nausea is defined as a subjective,unpleasant sensation associated with awareness of the urge to vomit. Retching is defined as the laboured, spastic, rhythmic contraction of the respiratory muscles without expulsion of the gastric contents.Vomiting is defined as the forceful expulsion of gastric contents from the mouth. Each episode will be recorded as either present or absent. If the patients had nausea, severity will be recorded using the following scale: 1, mild nausea; 2, moderate nausea; 3, severe nausea. If the patients had retching or vomiting, severity of episodes will be recorded using the following scale: 1, one episode; 2, two episodes; 3, three or more episodes
Measured: Up to 3 days after surgery
Incidence of emergence agitation(EA)
Emergence agitation(EA) is assessed with Richmond Agitation- Sedation Scale (RASS) .The RASS is divided into 10 levels (range of scores, -5 to +4, with higher scores indicating greater agitation). Patients with RASS score > +1 are evaluated as EA
Measured: Emergence agitation will be assessed immediately after extubation. Within 24 hours after surgery.
Intensity of pain within 3 days after surgery
Intensity of pain is assessed twice daily ((8-10 AM and 6-8 PM) with the Visual Analogue Scale ( an 11-point rating scale where 0=no pain and 10=the worst pain )
Measured: Up to 3 days after surgery
Postoperative recovery quality
Postoperative recovery quality is assessed with Quality of Recovery-40 scale（ QoR40）on the first day(6-8 PM) after surgery.
Measured: The first day(6-8 PM) after surgery
Length of stay in hospital after surgery
days
Measured: Up to 30 days after surgery
The incidence of non-delirium complications within 30 days after surgery
The occurrence of non-delirium complications, which are defined as newly occur medical conditions that are harmful for patients' recovery and require therapeutic intervention
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 posted15 Dec 2021
- Study start21 Mar 2022
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (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 in Old AgeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- wang yuelan, doctor, Study director, First Affiliated Hospital of Shandong First Medical University,China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158998
- Sponsor's protocol ID
- QianfoshanH PSPOD
- Status last verified
- May 2022
- First submitted
- 18 Nov 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang JH, Lv M, Zhang HX, Gao Y, Chen TT, Wan TT, Wang YL. Impact of propofol versus sevoflurane on the incidence of postoperative delirium in elderly patients after spine surgery: study protocol of a randomized controlled trial. Trials. 2022 Aug 30;23(1):720. doi: 10.1186/s13063-022-06687-x.
PubMed 36042484
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05158998
- Acronym / sponsor ID
- QianfoshanH PSPOD
- Conditions
- Delirium in Old Age, Anaesthetic
- Keywords
- delirium, spine surgery, anaesthetic, propofol, sevoflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 15 Dec 2021 (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.
Postoperative delirium in older adults is a common and costly complication after surgery. Propofol and sevoflurane are commonly used anesthetics to maintain sedation during spine surgery, and have different sedative and anti-inflammatory effects. The aim of this trial will be compare the impact of propofol versus sevoflurane on incidence of postoperative delirium in elderly patients after spine surgery.
Detailed description
Spine surgery is the third most common surgical procedure in older patients. With the increasing number of older patients undergoing spinal surgery, the risk of delirium after spinal surgery is currently expected to increase. The pathophysiological mechanisms of delirium remain poorly understood, leading models include neurotransmitter imbalance and neuroinflammation. Among precipitating factors, drugs (especially sedative hypnotic agents and anticholinergic agents), surgery, anesthesia, high pain levels, anemia, infections, acute illness, and acute exacerbation of chronic illness are the most commonly reported. Propofol and sevoflurane are commonly used anesthetics to maintain sedation during spinal surgery, and induce unconsciousness through different mechanisms. Meanwhile, previous studies have found that propofol and sevoflurane have different anti-inflammatory effects. Given their different sedative and anti-inflammatory effects, propofol and sevoflurane may have different effects on postoperative delirium. There are many studies to explore the effects of propofol and sevoflurane on postoperative delirium, but the conclusions are controversial. Therefore, a randomized, controlled, double-blind clinical study was designed to compare the impact of propofol and sevoflurane on delirium after spine surgery in elderly patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol group | Other | Drug: propofol infusionFor patients in the propofol group, anaesthesia will be maintained with propofol infusion(target controlled infusion), of which the target concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Propofol infusion will be stopped at the end of surgery. |
| sevoflurane group | Other | Drug: sevoflurane inhalationFor patients in the sevoflurane group, anaesthesia will be maintained with sevoflurane inhalation, of which the concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Sevoflurane inhalation will be stopped at the end of surgery. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age ≥65 years and ≤90 years;
- scheduled to undergo surgery for spinal, under general anaesthesia;
- American Society of Anesthesiology (ASA) I-III;
- agree to participate, and give signed written informed consents.
Key exclusion criteria (8 listed)
- family history or history of malignant hyperthermia;
- History of propofol or sevoflurane allergy;
- demonstrated cognitive impairment on the modified Mini-Mental State Examination (score, <24of 30 or <20 of 30 if the patient's education year was less than 6 years or<17 if the patient is Illiterate);
- planned postoperative intubation or transferred to ICU;
- severe visual or auditory handicap;
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 |
|---|---|---|
| propofol infusionFor patients in the propofol group, anaesthesia will be maintained with propofol infusion(target controlled infusion), of which the target concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)).Propofol infusion will be stopped at the end of surgery. | Drug | propofol group |
| sevoflurane inhalationFor patients in the sevoflurane group, anaesthesia will be maintained with sevoflurane inhalation, of which the concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Sevoflurane inhalation will be stopped at the end of surgery. | Drug | sevoflurane group |
Primary outcome
Incidence of delirium after surgery
Time frame: Between postoperative day 1 to discharge or day 7, whichever came first
Delirium is assessed twice daily (8-10 AM and 6-8 PM ) with the 3 minute diagnostic interview for Confusion Assessment Method.Researchers will review all progress notes and nursing documentation for delirium diagnoses, and a thorough medical record review process using the Chart-based Delirium Identification Instrument.
12 secondary outcomes
The day of postoperative delirium duration among patients who developed delirium
Time frame: Time from first to last delirium-positive day. Between postoperative day 1 to discharge or day 7, whichever came first
The day of total delirium-positive days among patients who developed delirium
Time frame: Between postoperative day 1 to discharge or day 7, whichever came first
The types of delirium in patients who developed delirium
Time frame: Between postoperative day 1 to discharge or day 7, whichever came first
The intubation time in postanesthesia care unit (PACU)
Time frame: From the patient transfered into PACU to tracheal extubation. Within 24 hours after surgery.
The length of stay in in postanesthesia care unit (PACU)
Time frame: Within 24 hours after surgery.
Incidence of postoperative shivering in PACU
Time frame: Within 24 hours after surgery.
Postoperative nausea and vomiting
Time frame: Up to 3 days after surgery
Incidence of emergence agitation(EA)
Time frame: Emergence agitation will be assessed immediately after extubation. Within 24 hours after surgery.
Intensity of pain within 3 days after surgery
Time frame: Up to 3 days after surgery
Postoperative recovery quality
Time frame: The first day(6-8 PM) after surgery
Length of stay in hospital after surgery
Time frame: Up to 30 days after surgery
The incidence of non-delirium complications within 30 days after surgery
Time frame: Up to 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Derived from this study: PubMed 36042484Wang JH, Lv M, Zhang HX, Gao Y, Chen TT, Wan TT, Wang YL. Impact of propofol versus sevoflurane on the incidence of postoperative delirium in elderly patients after spine surgery: study protocol of a randomized controlled trial. Trials. 2022 Aug 30;23(1):720. doi: 10.1186/s13063-022-06687-x.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
wang yuelan, doctor study director
First Affiliated Hospital of Shandong First Medical University,China.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol infusion and sevoflurane inhalation in people with Delirium in Old Age and Anaesthetic, run by Qianfoshan Hospital at 2 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wang jihua, master (13791125890, qy_wangjh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium after surgery (time frame: Between postoperative day 1 to discharge or day 7, whichever came first). 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 NCT05158998, 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 2 Jun 2022.