Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: low-dose neuroleptanalgesia
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuroleptanalgesia group<br>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<br>* 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.<br>|
| Placebo Comparator: Control group<br>The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure. | Drug: Placebo<br>* The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | This outcome will be measured using a numeric rating scale from 1 ( dissatisfaction ) to 3 (very satisfied) | Up to 7 days after surgery（or leaving hospital） | 
| 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） | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative delirium, Neuroleptanalgesia, Aged, Noncardiac major surgery