NCT05325762

Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders

Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders: a Multicentre, Randomized, Controlled Clinical Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 321 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep Disorder

Interventions

Type	Name	Description
DRUG	Propofol	At 21:00 on the night of tracheal extubation, propofol was administered intravenously with a microinjection pump for 2min. MOAAS/S was used to evaluate subjects 30 seconds after the end of administration.
DRUG	Dexmedetomidine	Dexmedetomidine was at 21 PM on the day of tracheal extubation: Dexmedetomidine was injected intravenously beginning at 00. During administration, patients were evaluated with MOAA/S every 2min.
DRUG	Saline	At 21:00 PM on the day of tracheal extubation, normal saline was injected intravenously. During the administration, patients were evaluated with MOAA/S every 2 minutes.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-10-25
• Completion: 2023-12-25
• First posted: 2022-04-13
• Last updated: 2022-10-03

Locations

4 sites across 1 country: China