Postoperative Delirium (POD)NCT06788743
Impact of Sevoflurane Versus Propofol on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial
A study testing TIVA ( anesthesia with propofol and remifentanil) and VA（anesthesia with sevoflurane and remifentanil） in people with Postoperative Delirium (POD) and Diabetes, run by Xijing Hospital at 1 site in China.
Trial summary
The present study is a multicenter， randomized controlled clinical trial, which plans to enroll 450 diabetic patients aged more than 60 years. The participants will be randomly assigned in a 1:1 ratio and will receive either propofol or sevoflurane for intraoperative anesthesia maintenance to evaluate the impact of… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium (POD), Diabetes
- What is being tested?
- TIVA ( anesthesia with propofol and remifentanil) and VA（anesthesia with sevoflurane and remifentanil）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 May 2026
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥60 years
- Elective surgery (with an expected duration of 2 hours or more)
- ASA grade Ⅰ-Ⅲ
- Voluntary participation and informed consent obtained
- Diabetes mellitus
Who cannot join
- Pre-operative BMI≥35 kg/m² (Class II obesity or above)
- Severe hepatic dysfunction (Child-Pugh class C) or pre-operative dialysis-dependent renal dysfunction
- Known neurological or psychiatric diseases (Parkinson's disease, depression, schizophrenia), or cognitive impairment (dementia)
- Severe visual or auditory impairments, language barriers, or patients who cannot cooperate
- Long-term use of sedatives, antipsychotic drugs, or long-term alcohol abuse
- Neurosurgical patients
- Patients with a known allergy to the drugs used in this study or those suspected of having propofol infusion syndrome
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710032
About this study
The present study is a multicenter， randomized controlled clinical trial, which plans to enroll 450 diabetic patients aged more than 60 years. The participants will be randomly assigned in a 1:1 ratio and will receive either propofol or sevoflurane for intraoperative anesthesia maintenance to evaluate the impact of these two anesthetic drugs on postoperative delirium. The aim of our study is to explore whether the use of propofol for anesthesia maintenance in elderly diabetic patients undergoing elective non-cardiac major surgery can reduce the incidence of postoperative delirium. This study will provide new perspectives for improving perioperative management in elderly diabetic patients and optimizing anesthesia management strategies to reduce the risk of postoperative delirium.
- Conditions
- Postoperative Delirium (POD), Diabetes
- Being tested
- TIVA ( anesthesia with propofol and remifentanil), VA（anesthesia with sevoflurane and remifentanil）
- Medical subject headings
- Emergence Delirium, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVA ( anesthesia with propofol and remifentanil)Drug
Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery
VA（anesthesia with sevoflurane and remifentanil）Drug
Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| TIVA | Experimental | Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery Receives: Drug: TIVA ( anesthesia with propofol and remifentanil) |
| VA | Experimental | Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery. Receives: Drug: VA（anesthesia with sevoflurane and remifentanil） |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of delirium
Postoperative delirium will be assessed daily at 8:00 AM and 6:00 PM from postoperative days 1 to 7, or until discharge, using the 3D-CAM scale.
Measured: within the first 7 postoperative days
Secondary outcomes (4)
The severity of POD
The severity of postoperative delirium will be evaluated with the 4-item CAM-S scale (total score: 7 points, where 0 points indicates no delirium; 1 point indicates mild delirium; 2 points indicates moderate delirium; 3-7 points indicate severe delirium).
Measured: within the first 7 postoperative days
The duration of POD
The total number of days with positive results.
Measured: within the first 7 postoperative days
The length of hospital stay
Measured: the first 7 postoperative days
Blood glucose levels
During the surgery, bedside capillary blood glucose levels will be measured using a portable blood glucose meter (capillary blood).
Measured: before anesthesia induction (T0), 1 h and 2 h after incision (T1, T2), at skin closure (T3), before PACU discharge (T4), and on post-operative days 1 and 2 (T5, T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Jun 2025
- Primary completion1 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- More trials run by Xijing 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788743
- Sponsor's protocol ID
- NCT06788743
- Status last verified
- Jun 2025
- First submitted
- 17 Jan 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sevoflurane Versus Propofol on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06788743
- Acronym / sponsor ID
- NCT06788743
- Conditions
- Postoperative Delirium (POD), Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 23 Jan 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.
The present study is a multicenter， randomized controlled clinical trial, which plans to enroll 450 diabetic patients aged more than 60 years. The participants will be randomly assigned in a 1:1 ratio and will receive either propofol or sevoflurane for intraoperative anesthesia maintenance to evaluate the impact of these two anesthetic drugs on postoperative delirium. The aim of our study is to explore whether the use of propofol for anesthesia maintenance in elderly diabetic patients undergoing elective non-cardiac major surgery can reduce the incidence of postoperative delirium. This study will provide new perspectives for improving perioperative management in elderly diabetic patients and optimizing anesthesia management strategies to reduce the risk of postoperative delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA | Experimental | Drug: TIVA ( anesthesia with propofol and remifentanil)Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery |
| VA | Experimental | Drug: VA（anesthesia with sevoflurane and remifentanil）Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥60 years
- Elective surgery (with an expected duration of 2 hours or more)
- ASA grade Ⅰ-Ⅲ
- Voluntary participation and informed consent obtained
- Diabetes mellitus
Key exclusion criteria (7 listed)
- Pre-operative BMI≥35 kg/m² (Class II obesity or above)
- Severe hepatic dysfunction (Child-Pugh class C) or pre-operative dialysis-dependent renal dysfunction
- Known neurological or psychiatric diseases (Parkinson's disease, depression, schizophrenia), or cognitive impairment (dementia)
- Severe visual or auditory impairments, language barriers, or patients who cannot cooperate
- Long-term use of sedatives, antipsychotic drugs, or long-term alcohol abuse
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 |
|---|---|---|
| TIVA ( anesthesia with propofol and remifentanil)Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery | Drug | TIVA |
| VA（anesthesia with sevoflurane and remifentanil）Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery. | Drug | VA |
Primary outcome
the incidence of delirium
Time frame: within the first 7 postoperative days
Postoperative delirium will be assessed daily at 8:00 AM and 6:00 PM from postoperative days 1 to 7, or until discharge, using the 3D-CAM scale.
4 secondary outcomes
The severity of POD
Time frame: within the first 7 postoperative days
The duration of POD
Time frame: within the first 7 postoperative days
The length of hospital stay
Time frame: the first 7 postoperative days
Blood glucose levels
Time frame: before anesthesia induction (T0), 1 h and 2 h after incision (T1, T2), at skin closure (T3), before PACU discharge (T4), and on post-operative days 1 and 2 (T5, T6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIVA ( anesthesia with propofol and remifentanil) and VA（anesthesia with sevoflurane and remifentanil） in people with Postoperative Delirium (POD) and Diabetes, run by Xijing 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 15 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of delirium (time frame: within 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 15 Sep 2026.