MAC vs TIVA Ambulatory Breast Augmentation
Condition: Breast Diseases
MeSH terms: Breast Diseases
Study type: Interventional
Phase: Phase 3

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 .
    

Detailed 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.
    

Intervention name(s): Remifentanil; general anesthetic
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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 intervention name(s): lidocaine, ropivaicaine; total intravenous anesthesia
Intervention MeSH terms: Lidocaine; Remifentanil; Anesthetics; Anesthetics, General
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other