MAC vs TIVA Ambulatory Breast Augmentation

Brief Summary

hypothesis: the combination of LA with remifentanil and ketofol [monitored anesthesia care (MAC)] for ambulatory breast augmentation may result in results in better QoR on day of surgery as compared with total i.v. anesthesia (TIVA) . The purpose of this study was to compare the QoR after MAC using remifentanil and ketofol with TIVA during ambulatory breast augmentation .

Intervention / Treatment

  • Drug: remifentanil
  • Drug: general anesthetic

Condition or Disease

  • Breast Diseases

Phase

Study Design

Study type: Interventional
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
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

Lead Sponsor: N/A
Responsible Party: N/A

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
Minimum Age: 21
Maximum Age: 50

More Details

NCT Number: NCT03764267
Other IDs: Ainshamsuni-MAC-wbakhet
Study URL: https://ClinicalTrials.gov/show/NCT03764267
Last updated: Jan 27, 2021