Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

Sponsor

RenJi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05068180

Collaborator

Shanghai 8th People's Hospital (Other)

200

Enrollment

Locations

Arms

6.1

Anticipated Duration (Months)

100

Patients Per Site

16.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms Colonic Neoplasms Rectal Neoplasms Sigmoid Neoplasms Liver Neoplasms Kidney Neoplasms Urinary Bladder Neoplasms Prostatic Neoplasms Osteoarthropathy Fractures, Bone Gynecologic Cancer	Drug: low-dose neuroleptanalgesia Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 5, 2021

Anticipated Primary Completion Date :

Apr 10, 2022

Anticipated Study Completion Date :

Apr 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neuroleptanalgesia group 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: 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.
Placebo Comparator: Control group The same volume of normal saline 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.

Arm

Intervention/Treatment

Experimental: Neuroleptanalgesia group

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: 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.

Placebo Comparator: Control group

The same volume of normal saline 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.

Outcome Measures

Primary Outcome Measures

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

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）]
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)
Incidence of postoperative hypoxia [Up to 1 day after surgery]
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）]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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