Back to resultsDesflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery
Primary Purpose
Desflurane, Propofol, Postoperative Sleep
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Desflurane Inhalation
Sponsored by
About this trial
This is an interventional prevention trial for Desflurane
Eligibility Criteria
Inclusion Criteria:
- （1）The operation time is 3-4 hours (2) Age 30-75 years old, BMI 18.5-25.0kg/m2, ASA grade I or II (3) There was no depression (MDI < 21) and cognitive impairment (MMSE ≥ 27) before operation (4) Those who voluntarily participate in the research and sign the informed consent
Exclusion Criteria:
- (1) The patients received adjuvant chemotherapy before operation (2) At present, they are taking psychoactive, opioid, anti anxiety and hypnotic drugs (3) Known or treated patients with apnea syndrome (4) Patients with other cancers
Sites / Locations
- Zhongnan Hospital of Wuhan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Desflurane Inhalation Group
Propofol Group
Arm Description
Anesthesia maintenance: Desflurane inhalation (MAC 1.0-1.2) Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min)
Anesthesia maintenance: Propofol TCI: 3-4ug / ml Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min)
Outcomes
Primary Outcome Measures
Pittsburgh sleep quality index
Secondary Outcome Measures
Pittsburgh sleep quality index
Total sleep time (TST), Rapid eye movement time (REM), Wakefulness after sleep onset (WASO)
Fitbit Charge 2™ objectively measured
Self-Rating Anxiety Scale Scores
Self-Rating Depression Scale Scores
Visual analogue scale scores
Flurbiprofen dose
Recovery time and quality (steward scores)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04805775
Brief Title
Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery
Official Title
Effect of Desflurane on Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery: A Non-inferiority Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
March 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study intends to investigate the effects of desflurane on postoperative sleep quality to guide perioperative patient management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Desflurane, Propofol, Postoperative Sleep, PSQI, Breast Tumor
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desflurane Inhalation Group
Arm Type
Experimental
Arm Description
Anesthesia maintenance: Desflurane inhalation (MAC 1.0-1.2) Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min)
Arm Title
Propofol Group
Arm Type
Active Comparator
Arm Description
Anesthesia maintenance: Propofol TCI: 3-4ug / ml Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min)
Intervention Type
Drug
Intervention Name(s)
Desflurane Inhalation
Intervention Description
Subjects were randomized in a 1:1 ratio to undergo breast surgery under maintenance of anesthesia with the classical intravenous anesthetic drug propofol (reference group) or the inhaled anesthetic drug desflurane (test group).
Primary Outcome Measure Information:
Title
Pittsburgh sleep quality index
Time Frame
Postoperative 3rd day
Secondary Outcome Measure Information:
Title
Pittsburgh sleep quality index
Time Frame
Postoperative 7th, and 30th days
Title
Total sleep time (TST), Rapid eye movement time (REM), Wakefulness after sleep onset (WASO)
Description
Fitbit Charge 2™ objectively measured
Time Frame
Postoperative 1st, 2nd, and 3rd days
Title
Self-Rating Anxiety Scale Scores
Time Frame
Postoperative 3rd, 7th, and 30th days
Title
Self-Rating Depression Scale Scores
Time Frame
Postoperative 3rd, 7th and 30th days
Title
Visual analogue scale scores
Time Frame
Postoperative 3rd, 7th and 30th days
Title
Flurbiprofen dose
Time Frame
Postoperative 1st, 2nd, and 3rd days
Title
Recovery time and quality (steward scores)
Time Frame
Up to 2 hours after operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Undergoing elective breast surgery
Age 18-75 years old
ASA-PS grade I or II
Those who voluntarily participate in the research and sign the informed consent
Exclusion Criteria:
Cognitive impairment (MMSE <27) before the operation
The patients received adjuvant chemotherapy before the operation
At present, they are taking psychoactive, opioid, anti-anxiety, and hypnotic drugs
Known or treated patients with obstructive sleep apnea
Patients with other cancers
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery
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