NCT05068180

Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

Low-dose Neuroleptanalgesia Reduce the Occurrences of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Major Surgery : a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Postoperative delirium（POD）is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.

Conditions

• Stomach Neoplasms
• Colonic Neoplasms
• Rectal Neoplasms
• Sigmoid Neoplasms
• Liver Neoplasms
• Kidney Neoplasms
• Urinary Bladder Neoplasms
• Prostatic Neoplasms
• Osteoarthropathy
• Fractures, Bone
• Gynecologic Cancer

Interventions

Type	Name	Description
DRUG	low-dose neuroleptanalgesia	Droperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure.
DRUG	Placebo	The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure.

Timeline

• Start date: 2021-10-05
• Primary completion: 2022-04-10
• Completion: 2022-04-10
• First posted: 2021-10-05
• Last updated: 2021-10-06

Locations

2 sites across 1 country: China