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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Disorder

Intervention / Treatment
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* Drug: Propofol
* Drug: Dexmedetomidine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were evaluated with MOAA/S by intravenous administration of propofol, dexmedetomidine, or normal saline until successful sleep (MOAA/S≤2)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol<br> | Drug: Propofol<br>* 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.<br>|
| Active Comparator: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* 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.<br>|
| Placebo Comparator: saline<br> | Drug: Saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of drug use | Adverse events and serious adverse events. | The first night after surgery | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Disorder, Propofol, Dexmedetomidine