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

NCT ID: NCT04036487

Last Updated: 2019-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-28

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Augmentation Inhalation Anesthesia Total Intravenous Anesthesia Quality of Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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IH group

Inhalation anesthesia will be given during transaxillary endoscopic breast augmentation.

Group Type EXPERIMENTAL

Desflurane

Intervention Type 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.

TIVA group

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chih-Cheng Hung

OTHER

Sponsor Role lead

Responsible Party

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Chih-Cheng Hung

Superintendent

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Chimay Plastic Surgery Clinic

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMTMU201701

Identifier Type: -

Identifier Source: org_study_id

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