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OpenTrials
Completed

NCT Number: NCT04036487

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

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.

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Key information

Conditions

Breast Augmentation Inhalation Anesthesia Quality of Recovery Total Intravenous Anesthesia

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chimay Plastic Surgery Clinic

Taipei, 106, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Quality of recovery, postoperative day one

    Time frame: 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.

  2. Quality of recovery, postoperative day two

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chih-Cheng Hung

Other

Registry information

Official study title

Chimay Plastic Surgery Clinic, Taipei

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 29, 2019
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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