MAC vs TIVA Ambulatory Breast Augmentation
Brief Summary
Condition or Disease
- Breast Diseases
Phase
Study Design
Study type: | Interventional |
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Status: | Completed |
Study results: | No Results Available |
Age: | 21 Years to 50 Years (Adult) |
Enrollment: | 80 () |
Funded by: | Other |
Masking |
Clinical Trial Dates
Start date: | Jan 01, 2014 | |
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Primary Completion: | Jan 01, 2017 | |
Completion Date: | Jan 01, 2018 | |
Study First Posted: | Dec 05, 2018 | |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Dec 05, 2018 |
Sponsors / Collaborators
Breast augmentation surgery is commonly performed on an ambulatory basis under under general anesthesia (GA) with propofol and remifentanil or local anesthesia (LA). Although surgeons perform this operation comfortably under GA, Patients have anxiety and fear of complications due to GA. In addition, they expect a good postoperative quality of recovery (QOR) including ability to resume common activities (work and daily activities) without suffering from moderate to severe pain.
The LA is advantageous over GA in that airway instrumentation is not necessary, favorable recovery profile, decrease postoperative pain and vomiting, increase patient satisfaction and decrease the cost . However, patient anxiety or pain often leading to conversion of LA to GA, which suggests the concomitant use of i.v. sedatives and analgesics as a supplement to LA.
The combination of remifentanil and ketofol (propofol, ketamine) for sedation during regional anesthesia and LA has been shown to be a safe, effective technique, capable of maintains adequate analgesia with conscious sedation, haemodynamic stability, and achieves lower incidence of postoperative nausea and vomiting with shorter recovery times.
Eligibility Criteria
Sex: | Female |
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Minimum Age: | 21 |
Maximum Age: | 50 |
More Details
NCT Number: | NCT03764267 |
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Other IDs: | Ainshamsuni-MAC-wbakhet |
Study URL: | https://ClinicalTrials.gov/show/NCT03764267 |