Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06958393

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Delirium - Postoperative Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Opioid-Free Anaesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Jinan, Shandong, 250014, China

Location contact

Yongtao Sun

CONTACT

+8618660795201

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Dexmedetomidine

Drug

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

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

esmolol

Drug

Maintenance 20-100 μg/kg/min during surgery

Sufentanil

Drug

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

Remifentanil

Drug

0.2-1.0 μg/kg/min maintenance

Primary outcomes

  1. Incidence of POD at discharge or within 7 days after surgery.

    Time frame: 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 (%).

Secondary outcomes

  1. 30-day All-Cause Mortality

    Time frame: Up to 30 days after surgery

    The proportion of participants who die from any cause during the initial hospitalization or within 30 calendar days following the index surgical procedure.The proportion of participants who die from any cause during the initial hospitalization or within 30 calendar days following the index surgical procedure. Results will be reported as the percentage of participants (%).

Other outcomes

  1. Intraoperative Haemodynamic Changes

    Time frame: Intraoperative (from anesthesia induction to surgical closure)

    Changes in mean arterial pressure and heart rate recorded during surgery. Results will be reported as the mean change from baseline (mmHg or beats per minute).

  2. Quality of Recovery-15 (QoR-15) Scores

    Time frame: 24, 48, and 72 hours after surgery

    QoR-15 scores assessed at 24 hours, 48 hours, and 72 hours after surgery. Results will be reported as the total score on the QoR-15 scale (range 0-150).

  3. Postoperative Complications

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

    Incidence of complications during postoperative hospitalization, including lung infection, urinary tract infection, cardiovascular and cerebrovascular accidents, abnormal liver function, postoperative bleeding, incision infection, deep venous thrombosis of the lower extremities, electrolyte imbalance, and hypoalbuminemia. Results will be reported as the percentage of participants (%).

  4. Pain Numerical Rating Scale (NRS) Score at 72 Hours

    Time frame: 72 hours after surgery

    Pain intensity assessed using the NRS scale (0-10) at 72 hours after surgery. Results will be reported as the mean NRS score.

  5. Incidence of Nausea and Vomiting at 72 Hours

    Time frame: 72 hours after surgery

    The proportion of participants experiencing nausea and/or vomiting at 72 hours after surgery. Results will be reported as the percentage of participants (%).

  6. Morphine Milligram Equivalent (MME) Consumption for Analgesics at 72 Hours

    Time frame: 72 hours after surgery

    Total opioid consumption converted to morphine milligram equivalents (MME) at 72 hours after surgery. Results will be reported as total MME (mg).

  7. Duration of Anaesthesia

    Time frame: From administration of anaesthetic agents to discontinuation of anaesthetic agents， up to 2 hours

    Time from induction of anaesthesia to discontinuation of anaesthetic agents. Results will be reported in minutes.

  8. Duration of Surgery

    Time frame: From skin incision to completion of wound closure, up to 2 hours

    Time from skin incision to the last suture. Results will be reported in minutes.

  9. Length of Stay in the Post-Anesthesia Care Unit (PACU)

    Time frame: From PACU admission to PACU discharge, measured in minutes, up to 60 minutes

    Time from arrival in the PACU to discharge from the PACU. Results will be reported in minutes.

  10. Length of Hospital Stay

    Time frame: From day of surgery to hospital discharge, up to 30 days

    Total number of days from surgery to hospital discharge. Results will be reported in days.

  11. Long-Term Cognitive Function at 6 Months

    Time frame: 6 months after surgery

    Cognitive function assessed at 6 months after surgery using standardized cognitive testing methods. Results will be reported as cognitive assessment scores.

Study contacts

Contact information is provided by the study sponsor or research team.

Yongtao Sun, Ph.D. in Anesthesiology

CONTACT

[email protected]

+86 18660795201

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery: a Single-centre, Prospective, Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 6, 2025
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.