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

Quality of Recovery Clinical Trial

Official title:

Chimay Plastic Surgery Clinic, Taipei

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036487
• Other study ID #: CMTMU201701
• Status: Completed
• Phase: N/A
• Start date: July 28, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: August 2019
• Source: Chimay Plastic Surgery Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 31, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breast Augmentation
• Inhalation Anesthesia
• Quality of Recovery
• Total Intravenous Anesthesia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Chimay Plastic Surgery Clinic	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chih-Cheng Hung

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	On the 1st postoperative day
Primary	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.	On the 2nd postoperative day