Status:
NOT_YET_RECRUITING
Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery
Lead Sponsor:
Qianfoshan Hospital
Conditions:
Delirium - Postoperative
Opioid-Free Anaesthesia
Eligibility:
All Genders
65-90 years
Phase:
PHASE4
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 deat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 12 2026
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT06958393
Start Date
May 20 2025
End Date
May 12 2026
Last Update
May 6 2025
Active Locations (1)
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1
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China, 250014