Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

Phase 4

• Conditions: Sigmoid Neoplasms; Urinary Bladder Neoplasms; Prostatic Neoplasms; Stomach Neoplasms; Kidney Neoplasms; Fractures, Bone; Colonic Neoplasms; Liver Neoplasms; Gynecologic Cancer; Rectal Neoplasms
• Interventions: Drug: Placebo; Drug: low-dose neuroleptanalgesia

• Registration Number: NCT05068180
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-23
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Study Start: 2021-10-05
• Study First Posted: 2021-10-05
• Last Update Posted: 2021-10-06
• Primary Completion: 2022-04-10
• Study Completion: 2022-04-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age ≥ 65 years old and ≤ 85 years old;
2. Selective non-cardiac major surgery;
3. Informed consent and voluntary participation in the trial;
4. ASA class I-II;
5. Anticipated operation duration ≥ 2 hours;
6. No plan to ICU after operation.

Exclusion Criteria

1. Neurosurgery;
2. Patients with neurological and mental diseases: such as basal ganglia disease, Parkinson's syndrome, severe central nervous depression, Alzheimer's disease , etc;
3. Patients with prolonged Q-T interval, cardiac repolarization disorder and other severe arrhythmia;
4. Patients with severe cardiopulmonary disease, liver and kidney dysfunction;
5. Allergic or contraindications to droperidol or fentanyl citrate;
6. Admitted to ICU after operation.
7. Operation duration < 2 hours;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure.
Neuroleptanalgesia group	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.

Primary Outcome Measures

Name	Time	Method
Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery	Up to 7 days after surgery（or leaving hospital）

Secondary Outcome Measures

Name	Time	Method
Incidence of major serious complications and serious arrhythmia	Up to 7 days after surgery（or leaving hospital）
Duration of postoperative delirium	Up to 7 days after surgery（or leaving hospital）
Length of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 7 days
Incidence of postoperative nausea and vomiting	Up to 7 days after surgery（or leaving hospital）
Incidence of postoperative hypoxia	Up to 1 day after surgery
Patients' satisfaction	Up to 7 days after surgery（or leaving hospital）	This outcome will be measured using a numeric rating scale from 1 ( dissatisfaction ) to 3 (very satisfied)

Trial Locations

Locations (2)

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanghai Eighth People's Hospital; 🇨🇳 Shanghai, Shanghai, China