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Completed

NCT Number: NCT03764267

MAC vs TIVA Ambulatory Breast Augmentation

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 .

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Key information

Conditions

Breast Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I, II

Exclusion criteria

  • ASA III

Treatment and study plan

Remifentanil

Drug

Five minutes before infiltration of the local anesthestic by the surgeon, patients received an initial maintenance infusion of remifentanil 0.1 µg/kg/min and ketofol mixture 0.3 ml/kg (propofol 25 µg /kg/min and ketamine 10 µg/kg/min). ketofol mixture was prepared in a ratio of 1:2.5 (100 mg ketamine 2 mL (100 mg), propofol 1% 25 mL (250 mg), and glucose 5% 23 ml, total volume of 50 ml, each ml contain 2 mg ketamine + 5 mg propofol).

Throughout the surgery, titration of the infusion rate of the remifentanil and ketofol were indicated by vital signs and expression of pain

Other names: lidocaine, ropivaicaine

General anesthetic

Drug

general anesthetic was induced with a bolus dose of remifentanil (1 ug/kg over 30 second) and propofol (2 mg/kg) followed by insertion of a laryngeal mask airway (LMA). After the induction of anaesthesia and securing the airway, patient' lungs were ventilated with volume controlled ventilation, 50% oxygen/air mixtures in a circle system. .Anesthesia was maintained with remifentanil (0.5 ug/ kg/ min) and propofol (5 mg/kg/h). Remifentanil and propofol titrated to keep heart rate and the blood pressure within 20% of the baseline values and maintain BIS between 40 and 60, respectively. Patient movements were treated with additional i.v. bolus doses of remifentanil 0.5 ug/kg

Other names: total intravenous anesthesia

Primary outcomes

  1. Quality of recovery

    Time frame: 24 hours postoperative

    Quality of recovery-40 (QoR-40) questionnaire, which includes five general quality of life dimensions: physical independence (5 items), pain (7 items), .emotional state (9 items), psychological support (7 items), and physical independence (5 items). Each item was graded with a 5-point score: none of the time, some of the time,usually, most of the time and all of the time. The total score on the QoR- 40 questionnaire ranges from 40 to 200 representing, respectively, extremely poor to excellent

Secondary outcomes

  1. Recovery room readiness times

    Time frame: 24 hours postoperative

    minutes

  2. home readiness times

    Time frame: 24 hours postoperative

    minutes

  3. adverse events

    Time frame: 24 hours postoperative

    vomiting

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Monitored Anesthesia Care Using Remifentanil and Ketofol Results in a Superior Quality of Recovery Compared With Total Intravenous Anesthesia in Ambulatory Breast Augmentation

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Dec 5, 2018
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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