Effects of General Anesthesia on Quality of Recovery After Transaxillary Endoscopic Breast Augmentation
Primary Purpose
Breast Augmentation, Inhalation Anesthesia, Total Intravenous Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Desflurane
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Breast Augmentation
Eligibility Criteria
Inclusion Criteria:
- Patients are appropriate for undergoing transaxillary endoscopic breast augmentation
- Age between 20-65 years
- Physical Status I or II as defined by the American Society of Anesthesiologists (ASA) Physical Status Classification System
Exclusion Criteria:
- Having difficulty reading or hearing
- Diagnosed with addictive disorder
- Diagnosed with psychiatric disorder
- Physical Status III-VI as defined by the ASA Physical Status Classification System
- Presence of acute infection or inflammatory condition (e.g., fever).
Sites / Locations
- Chimay Plastic Surgery Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IH group
TIVA group
Arm Description
Inhalation anesthesia will be given during transaxillary endoscopic breast augmentation.
Total intravenous anesthesia will be given during transaxillary endoscopic breast augmentation.
Outcomes
Primary Outcome Measures
Quality of recovery, postoperative day one
Quality of recovery is assessed by the 15-item Quality of Recovery (QoR-15) questionnaire. The total score of the 15-item QoR ranges from 0 to 150, and a higher score indicates a better outcome.
Quality of recovery, postoperative day two
Quality of recovery is assessed by the 15-item Quality of Recovery (QoR-15) questionnaire. The total score of the 15-item QoR ranges from 0 to 150, and a higher score indicates a better outcome.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04036487
Brief Title
Effects of General Anesthesia on Quality of Recovery After Transaxillary Endoscopic Breast Augmentation
Official Title
Chimay Plastic Surgery Clinic, Taipei
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chih-Cheng Hung
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Among aesthetic or cosmetic surgeries, breast augmentation was the most frequently performed and the endoscopic transaxillary approach has become the preferred incision for Asian women. As breast augmentation must be performed under general anesthesia accompanied by its effects and potential complications, types of general anesthesia may affect the quality of recovery. Currently, the two most common techniques of general anesthesia are inhalation anesthesia (IH) and total intravenous anesthesia (TIVA). The effects of these types of general anesthesia on the quality of recovery have been investigated for numerous surgical procedures. However, no prior studies have analyzed different types of anesthesia used for performing transaxillary endoscopic breast augmentation. This prospective, parallel, randomized controlled study will evaluate the effects of inhalation anesthesia vs. total intravenous anesthesia on the quality of recovery in patients undergoing transaxillary endoscopic breast augmentation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Augmentation, Inhalation Anesthesia, Total Intravenous Anesthesia, Quality of Recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IH group
Arm Type
Experimental
Arm Description
Inhalation anesthesia will be given during transaxillary endoscopic breast augmentation.
Arm Title
TIVA group
Arm Type
Active Comparator
Arm Description
Total intravenous anesthesia will be given during transaxillary endoscopic breast augmentation.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Anesthesia is maintained by desflurane in an oxygen air mixture of 60/40%. If inadequate depth of anesthesia is observed, the end-expiratory concentration of desflurane would be increased.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Anesthesia is maintained by propofol 100-200 μg/kg/min. If inadequate depth of anesthesia is observed, the rate of propofol infusion would be increased.
Primary Outcome Measure Information:
Title
Quality of recovery, postoperative day one
Description
Quality of recovery is assessed by the 15-item Quality of Recovery (QoR-15) questionnaire. The total score of the 15-item QoR ranges from 0 to 150, and a higher score indicates a better outcome.
Time Frame
On the 1st postoperative day
Title
Quality of recovery, postoperative day two
Description
Quality of recovery is assessed by the 15-item Quality of Recovery (QoR-15) questionnaire. The total score of the 15-item QoR ranges from 0 to 150, and a higher score indicates a better outcome.
Time Frame
On the 2nd postoperative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients are appropriate for undergoing transaxillary endoscopic breast augmentation
Age between 20-65 years
Physical Status I or II as defined by the American Society of Anesthesiologists (ASA) Physical Status Classification System
Exclusion Criteria:
Having difficulty reading or hearing
Diagnosed with addictive disorder
Diagnosed with psychiatric disorder
Physical Status III-VI as defined by the ASA Physical Status Classification System
Presence of acute infection or inflammatory condition (e.g., fever).
Facility Information:
Facility Name
Chimay Plastic Surgery Clinic
City
Taipei
ZIP/Postal Code
106
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of General Anesthesia on Quality of Recovery After Transaxillary Endoscopic Breast Augmentation
We'll reach out to this number within 24 hrs