Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

RenJi Hospital200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

200

Conditions

Stomach Neoplasms Colonic Neoplasms Rectal Neoplasms Sigmoid Neoplasms

Interventions

low-dose neuroleptanalgesiaDRUG

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.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 Years

Medical Language ↔ Plain English

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;

Locations (2)

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Eighth People's Hospital

Shanghai, Shanghai Municipality, China

NOT_YET_RECRUITING