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MAC vs TIVA Ambulatory Breast Augmentation

A

Ain Shams University

Status and phase

Completed
Phase 3

Conditions

Breast Diseases

Treatments

Drug: general anesthetic
Drug: Remifentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT03764267
Ainshamsuni-MAC-wbakhet

Details and patient eligibility

About

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 .

Full description

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.

Enrollment

80 patients

Sex

Female

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • ASA I, II

Exclusion criteria

  • ASA III

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

remifentanil
Active Comparator group
Description:
MAC group
Treatment:
Drug: Remifentanil
general anesthetic
Active Comparator group
Description:
TIVA group
Treatment:
Drug: general anesthetic

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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