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

Phase 4

• Conditions: Sleep Disorder
• Interventions: Drug: Saline; Drug: Dexmedetomidine; Drug: Propofol

• Registration Number: NCT05325762
• Lead Sponsor: Xiangya Hospital of Central South University

Brief 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.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-27
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-13
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03
• Study Start: 2022-12-01
• Primary Completion: 2023-10-25
• Study Completion: 2023-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

• age ≥ 60 years old
• Chronic insomnia
• Pittsburgh Sleep Quality Index>5 points
• Daytime functional impairment (component Ⅶ ≥2 points in PSQI)
• Patients undergoing elective surgery
• Patients to be admitted to ICU after surgery
• Voluntarily participate in the study and sign the informed consent

Exclusion Criteria

• Subjects with severe hemodynamic instability
• Subjects with difficult airway
• Patients with other sleep disorders (including sleep apnea syndrome, exercise-related sleep disorders and other types of sleep disorders)
• Subjects requiring sedation, mechanical ventilation, or sleep prior to medication;
• Severe liver dysfunction (Child-Pugh GRADE C)
• Severe renal dysfunction (requiring dialysis before surgery)
• Patients with allergies to study drugs and related ingredients
• Patients with severe dementia, low cognitive function, language impairment, severe hearing or vision impairment, mental disorder, coma and other conditions cannot complete the assessment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	Saline	-
Dexmedetomidine	Dexmedetomidine	-
Propofol	Propofol	-

Primary Outcome Measures

Name	Time	Method
Sleep improvement efficiency	Preoperative, postoperative 1-7 days, postoperative 30 days	The total score of The Leeds Sleep Evaluation Questionaire was \> 100 （The score ranges from 0 to 100， a higher scores mean a better outcome.）, the incubation period of sleep was \< 30min, the sleep duration was \> 5h, and the sleep quality was good. Assess changes at several points in time.

Secondary Outcome Measures

Name	Time	Method
Safety of drug use	The first night after surgery	Adverse events and serious adverse events.
Sleep scale assessment	Preoperative, postoperative 1-7 days, postoperative 30 days	Preoperative and postoperative sleep was assessed using Pittsburgh sleep quality index. Assess changes at several points in time.

Trial Locations

Locations (4)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China