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Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders: a Multicentre, Randomized, Controlled Clinical Study
This study intends to conduct postoperative sleep intervention for elderly patients with sleep disorders undergoing surgery. We hope to explore whether propofol can improve the postoperative sleep quality of elderly patients with sleep disorders, prevent the occurrence of postoperative delirium in elderly patients, relieve patients' pain, promote patients' postoperative rehabilitation, and provide reference for realizing the rapid rehabilitation of elderly patients with sleep disorders through intravenous administration of research drugs, on the premise of improving patient comfort and ensuring patient safety.
The purpose of this multicenter, randomized, controlled clinical study was to evaluate the efficacy and safety of propofol compared with normal saline and dexmedetomidine in the effect of postoperative sleep quality in elderly subjects with sleep disorders. Subjects were randomly assigned to propofol group, dexmedetomidine group or normal saline control group. Propofol group: At 21:00 on the night of tracheal extubation, propofol was administered intravenously. MOAAS/S was used to evaluate subjects 30 seconds after the end of administration.Dexmedetomidine group: treated with dexmedetomidine at 21 PM on the day of tracheal extubation. During administration, patients were evaluated with MOAA/S every 2min. Normal saline control group: 21 on the night of tracheal extubation: Normal saline was injected intravenously at the rate of 0.5ml/(kg.h) beginning at 00. During the administration, patients were evaluated with MOAA/S every 2min. The effect of drugs on sleep improvement was evaluated by subjective scale and objective electrical monitoring.
Age
60 - 85 years
Sex
ALL
Healthy Volunteers
No
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Start Date
December 1, 2022
Primary Completion Date
October 25, 2023
Completion Date
December 25, 2023
Last Updated
October 3, 2022
321
ESTIMATED participants
Propofol
DRUG
Dexmedetomidine
DRUG
Saline
DRUG
Lead Sponsor
Xiangya Hospital of Central South University
NCT06441864
NCT07426991
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