Quality of Recovery Clinical Trial
Official title:
Chimay Plastic Surgery Clinic, Taipei
NCT number | NCT04036487 |
Other study ID # | CMTMU201701 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 28, 2017 |
Est. completion date | May 31, 2018 |
Verified date | August 2019 |
Source | Chimay Plastic Surgery Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chimay Plastic Surgery Clinic | Taipei |
Lead Sponsor | Collaborator |
---|---|
Chih-Cheng Hung |
Taiwan,
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 |
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