Back to resultsEffect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders
Primary Purpose
Sleep Disorder
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Propofol
Dexmedetomidine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disorder focused on measuring Sleep Disorder, Propofol, Dexmedetomidine
Eligibility Criteria
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
Sites / Locations
- Beijing Tiantan Hospital, Capital Medical University
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
- The First Affiliated Hospital of China Medical University
- West China Hospital, Sichuan University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Propofol
Dexmedetomidine
saline
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Safety of drug use
Adverse events and serious adverse events.
Sleep scale assessment
Preoperative and postoperative sleep was assessed using Pittsburgh sleep quality index. Assess changes at several points in time.
Full Information
NCT ID
NCT05325762
First Posted
February 27, 2022
Last Updated
September 29, 2022
Sponsor
Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT05325762
Brief Title
Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders
Official Title
Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders: a Multicentre, Randomized, Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
October 25, 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
Keywords
Sleep Disorder, Propofol, Dexmedetomidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients were evaluated with MOAA/S by intravenous administration of propofol, dexmedetomidine, or normal saline until successful sleep (MOAA/S≤2)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The blind group included the principal investigator, and any other participants in the recording, evaluation, analysis, or review of efficacy/safety endpoint data, who were primarily responsible for study operations other than drug administration (e.g., subject screening, efficacy and safety indicator recording, statistical analysis, etc.).
Allocation
Randomized
Enrollment
321 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Experimental
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Title
saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep improvement efficiency
Description
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.
Time Frame
Preoperative, postoperative 1-7 days, postoperative 30 days
Secondary Outcome Measure Information:
Title
Safety of drug use
Description
Adverse events and serious adverse events.
Time Frame
The first night after surgery
Title
Sleep scale assessment
Description
Preoperative and postoperative sleep was assessed using Pittsburgh sleep quality index. Assess changes at several points in time.
Time Frame
Preoperative, postoperative 1-7 days, postoperative 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
e wang, M.D.
Phone
18874889950
Ext
+86
Email
ewang324@163.com
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
12. IPD Sharing Statement
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Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders
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