Clinical trial NCT06958393: Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery
Official title: Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery: a Single-centre, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Delirium - Postoperative
Opioid-Free Anaesthesia
Keywords: elderly patients
opioid-free anaesthesia
postoperative delirium
gastrointestinal surgery
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 406
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 65 years
2. American Society of Anesthesiologists (ASA) physical status classification I-III
3. Scheduled for elective gastrointestinal surgery under general anaesthesia
4. Body mass index (BMI) between 18.0 and 30.0 kg/m²

Exclusion Criteria:

1. Refusal to undergo surgery
2. Emergency surgery
3. Language impairment or severe hearing or visual deficits that hinder effective communication with research or surgical staff
4. History of neurological or psychiatric disorders, including Alzheimer's disease (AD), other forms of dementia, stroke, or psychosis
5. Long-term use of psychotropic medications (e.g., clozapine, risperidone, olanzapine, haloperidol, chlorpromazine)
6. Cardiac or craniocerebral surgery within the past year
7. Participation in other interventional clinical studies within the past 3 months
8. Preoperative cognitive impairment defined as a modified Telephone Interview for Cognitive Status (TICS-M) score ≤ 27
9. Patients will only be enrolled once, even if a subsequent surgery related to the primary procedure is performed

Primary outcomes:
measure: Incidence of POD at discharge or within 7 days after surgery.
timeFrame: Discharge or within 7 days after surgery
Secondary outcomes:
measure: 30-day All-Cause Mortality
timeFrame: Up to 30 days after surgery
Other outcomes:
measure: Intraoperative Haemodynamic Changes
timeFrame: Intraoperative (from anesthesia induction to surgical closure)
measure: Quality of Recovery-15 (QoR-15) Scores
timeFrame: 24, 48, and 72 hours after surgery
measure: Postoperative Complications
timeFrame: From day of surgery through hospital discharge, up to 30 days
measure: Pain Numerical Rating Scale (NRS) Score at 72 Hours
timeFrame: 72 hours after surgery
measure: Incidence of Nausea and Vomiting at 72 Hours
timeFrame: 72 hours after surgery
measure: Morphine Milligram Equivalent (MME) Consumption for Analgesics at 72 Hours
timeFrame: 72 hours after surgery
measure: Duration of Anaesthesia
timeFrame: From administration of anaesthetic agents to discontinuation of anaesthetic agents， up to 2 hours
measure: Duration of Surgery
timeFrame: From skin incision to completion of wound closure, up to 2 hours
measure: Length of Stay in the Post-Anesthesia Care Unit (PACU)
timeFrame: From PACU admission to PACU discharge, measured in minutes, up to 60 minutes
measure: Length of Hospital Stay
timeFrame: From day of surgery to hospital discharge, up to 30 days
measure: Long-Term Cognitive Function at 6 Months
timeFrame: 6 months after surgery
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
References: