Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

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

Treatments: Drug: low-dose neuroleptanalgesia; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05068180

KY2020-125

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Neuroleptanalgesia group

Experimental group

Description:

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.

Treatment:

Drug: low-dose neuroleptanalgesia

Control group

Placebo Comparator group

Description:

The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure.

Treatment:

Drug: Placebo