Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery

NCT06958393 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: opioid-free anaesthesia
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium - Postoperative; Opioid-Free Anaesthesia

Keywords

elderly patients; opioid-free anaesthesia; postoperative delirium; gastrointestinal surgery

Outcome Measures

Primary Outcomes (1)

• 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 (%).

  Discharge or within 7 days after surgery

Secondary Outcomes (1)

• 30-day All-Cause Mortality

  Up to 30 days after surgery

Other Outcomes (11)

• Intraoperative Haemodynamic Changes

  Intraoperative (from anesthesia induction to surgical closure)

• Quality of Recovery-15 (QoR-15) Scores

  24, 48, and 72 hours after surgery

• Postoperative Complications

  From day of surgery through hospital discharge, up to 30 days

Study Arms (2)

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.

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.

Drug: Dexmedetomidine; Drug: Esketamine; Drug: Esmolol

Interventions

Dexmedetomidine DRUG

Continuous infusion at 0.5-1.0 μg/kg/h during surgery

Opioid-Free Anaesthesia (OFA) Group

Esketamine DRUG

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

Opioid-Free Anaesthesia (OFA) Group

Esmolol DRUG

Maintenance 20-100 μg/kg/min during surgery

Opioid-Free Anaesthesia (OFA) Group

Sufentanil DRUG

0.3-0.5 μg/kg induction; 0.15 μg/kg at closure; 2 μg/kg in 100 mL for PCIA

Opioid-Based Anaesthesia (OBA) Group

Remifentanil DRUG

0.2-1.0 μg/kg/min maintenance

Opioid-Based Anaesthesia (OBA) Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

Related Publications (1)

• 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.

  PMID: 40721742 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Esketamine; esmolol; Sufentanil; Remifentanil

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Yongtao Sun, Ph.D. in Anesthesiology

CONTACT

+86 18660795201; ytsun@sdfmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 6, 2025
• Study Start: May 20, 2025
• Primary Completion: January 5, 2026
• Study Completion (Estimated): May 12, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-04

Locations

CN (1)