Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65-90
SponsorQianfoshan Hospital
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine
DrugContinuous infusion at 0.5-1.0 μg/kg/h during surgery
Esketamine
DrugInduction 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
DrugMaintenance 20-100 μg/kg/min during surgery
Sufentanil
Drug0.3-0.5 μg/kg induction; 0.15 μg/kg at closure; 2 μg/kg in 100 mL for PCIA
Remifentanil
Drug0.2-1.0 μg/kg/min maintenance
Treatment groups
406 Participants
are divided into 2 treatment groupsGroup A: Opioid-Based Anaesthesia (OBA) GroupActive comparator 2 interventions
Group B: Opioid-Free Anaesthesia (OFA) GroupExperimental treatment 3 interventions
Trial outcomes
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 (%).
Time frame
Discharge or within 7 days after surgerySecondary outcomes
1
30-day All-Cause Mortality
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 (%).
Time frame
Up to 30 days after surgeryOther outcomes
1
Intraoperative Haemodynamic Changes
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).
Time frame
Intraoperative (from anesthesia induction to surgical closure)2
Quality of Recovery-15 (QoR-15) Scores
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).
Time frame
24, 48, and 72 hours after surgery3
Postoperative Complications
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 (%).
Time frame
From day of surgery through hospital discharge, up to 30 days4
Pain Numerical Rating Scale (NRS) Score at 72 Hours
Pain intensity assessed using the NRS scale (0-10) at 72 hours after surgery. Results will be reported as the mean NRS score.
Time frame
72 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
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