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

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05325762
• Other study ID #: XiangyaH1
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 1, 2022
• Est. completion date: December 25, 2023

Study information

• Verified date: February 2022
• Source: Xiangya Hospital of Central South University
• Contact: e wang, M.D.
• Phone: 18874889950
• Email: ewang324[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 321
• Est. completion date: December 25, 2023
• Est. primary completion date: October 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• age = 60 years old

• Chronic insomnia

• Pittsburgh Sleep Quality Index>5 points

• Daytime functional impairment (component ? =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

Related Conditions & MeSH terms

• Disease
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep improvement efficiency	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.	Preoperative, postoperative 1-7 days, postoperative 30 days
Secondary	Safety of drug use	Adverse events and serious adverse events.	The first night after surgery
Secondary	Sleep scale assessment	Preoperative and postoperative sleep was assessed using Pittsburgh sleep quality index. Assess changes at several points in time.	Preoperative, postoperative 1-7 days, postoperative 30 days