MAC vs TIVA Ambulatory Breast Augmentation

NCT03764267 | Completed Phase 3 DMC

• 1 other identifier: Ainshamsuni-MAC-wbakhet
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Breast Diseases

Outcome Measures

Primary Outcomes (1)

• Quality of recovery

  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

  24 hours postoperative

Secondary Outcomes (3)

• Recovery room readiness times

  24 hours postoperative

• home readiness times

  24 hours postoperative

• adverse events

  24 hours postoperative

Study Arms (2)

remifentanil

ACTIVE COMPARATOR

MAC group

Drug: Remifentanil

general anesthetic

ACTIVE COMPARATOR

TIVA group

Drug: general anesthetic

Interventions

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

Also known as: lidocaine, ropivaicaine

remifentanil

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

Also known as: total intravenous anesthesia

general anesthetic

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I, II

You may not qualify if:

• ASA III

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Breast Diseases

Interventions

Remifentanil; Lidocaine; Anesthetics, General

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lectrure of anesthesia

Study Record Dates

• First Submitted: December 1, 2018
• First Posted: December 5, 2018
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12