Clinical trial NCT06788743: Impact of Volatile Versus Total Intravenous Anesthesia on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial
Official title: Impact of Volatile Versus Total Intravenous Anesthesia on Postoperative Delirium in Elderly Patients Undergoing Non-Cardiac Surgery: Study Protocol of a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Delirium (POD)
Diabetes
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 450
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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. Exploratory analysis was conducted to observe the differences in perioperative levels of blood glucose, serum insulin, inflammatory factors (IL-6, IL-1β, TNF-α), neuroinjury markers (S-100β protein, neuron-specific enolase) between the two groups. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 who are expected to require hepatic portal blockage during surgery
* Patients who are expected to be transferred to ICU after surgery
* Patients with a known allergy to the drugs used in this study or those suspected of having propofol infusion syndrome

Primary outcomes:
measure: the incidence of delirium
timeFrame: within the first 7 postoperative days
Secondary outcomes:
measure: The severity of POD
timeFrame: within the first 7 postoperative days
measure: The duration of POD
timeFrame: within the first 7 postoperative days
measure: The length of hospital stay
timeFrame: the first 7 postoperative days
measure: Blood glucose levels
timeFrame: before anesthesia induction (T0), intubation (T1), skin incision (T2), 1 and 2 hours after the start of surgery (T3, T4), suturing (T5), extubation (T6), before discharge from PACU (T7), postoperative days 1 and 2 (T8, T9)
measure: Insulin levels
timeFrame: Preoperative and postoperative 1-hour, 2-hour
measure: IL-6, IL-1β, and TNF-α levels
timeFrame: Preoperative and postoperative days 1 and 2
measure: S-100β protein and neuron-specific enolase (NSE) levels
timeFrame: Preoperative and postoperative days 1 and 2
Other outcomes:
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