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

NCT04036487 | Completed

• 1 other identifier: CMTMU201701
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

IH group

EXPERIMENTAL

Inhalation anesthesia will be given during transaxillary endoscopic breast augmentation.

Drug: Desflurane

TIVA group

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

Desflurane DRUG

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.

IH group

Propofol DRUG

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.

TIVA group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chih-Cheng Hung: lead

Study Sites (1)

Chimay Plastic Surgery Clinic

Taipei, 106, Taiwan

Location

MeSH Terms

Interventions

Desflurane; Propofol

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Superintendent

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: July 28, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 31, 2018
• Last Updated: August 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)