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MAC vs TIVA Ambulatory Breast Augmentation

NCT03764267 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-12-05

No results posted yet for this study

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 .

Conditions

  • Breast Diseases

Interventions

DRUG

Remifentanil

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

DRUG

general anesthetic

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2017-01-01
Completion
2018-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764267 on ClinicalTrials.gov