Effects of General Anesthesia on Quality of Recovery After Transaxillary Endoscopic Breast Augmentation

Sponsor

Chih-Cheng Hung (Other)

Overall Status

Completed

CT.gov ID

NCT04036487

Collaborator

(none)

104

Enrollment

Location

Arms

10.1

Actual Duration (Months)

10.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Augmentation Inhalation Anesthesia Total Intravenous Anesthesia Quality of Recovery	Drug: Desflurane Drug: Propofol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Chimay Plastic Surgery Clinic, Taipei

Actual Study Start Date :

Jul 28, 2017

Actual Primary Completion Date :

May 30, 2018

Actual Study Completion Date :

May 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IH group Inhalation anesthesia will be given during transaxillary endoscopic breast augmentation.	Drug: Desflurane 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.
Active Comparator: TIVA group Total intravenous anesthesia will be given during transaxillary endoscopic breast augmentation.	Drug: Propofol 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.

Arm

Intervention/Treatment

Experimental: IH group

Inhalation anesthesia will be given during transaxillary endoscopic breast augmentation.

Drug: Desflurane

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.

Active Comparator: TIVA group

Total intravenous anesthesia will be given during transaxillary endoscopic breast augmentation.

Drug: Propofol

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.

Outcome Measures

Primary Outcome Measures

Quality of recovery, postoperative day one [On the 1st postoperative day]
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 [On the 2nd postoperative day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chimay Plastic Surgery Clinic	Taipei		Taiwan	106

Sponsors and Collaborators

Chih-Cheng Hung

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chih-Cheng Hung, Superintendent, Chimay Plastic Surgery Clinic

ClinicalTrials.gov Identifier:

NCT04036487

Other Study ID Numbers:

CMTMU201701

First Posted:

Jul 29, 2019

Last Update Posted:

Aug 12, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Aspiration

Propofol

Desflurane

Study Results

No Results Posted as of Aug 12, 2019