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Clinical Trials/NCT02631525
NCT02631525
Completed
Phase 4

A Comparison of Post-operative Recovery Between Remifentanil-propofol and Remifentanil-desflurane Anesthesia Guided by Bispectral Index Monitoring

Federal University of Minas Gerais0 sites40 target enrollmentAugust 2014

Overview

Phase
Phase 4
Intervention
Propofol
Conditions
Delayed Emergence From Anesthesia
Sponsor
Federal University of Minas Gerais
Enrollment
40
Primary Endpoint
Extubation Time
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative recovery than remifentanil-propofol.

Detailed Description

It is a randomized, double blind study, involving 40 adult female patients submitted to general anesthesia. The patients were distributed into 2 groups: remifentanil-propofol-based anesthesia and remifentanil-desflurane-based anesthesia groups. Bispectral index (BIS) monitoring guided the anesthesia by setting target BIS range value between 40 and 60. Anesthetics were adjusted to reached that. Primary outcome was: extubation time (time from anesthetic discontinuation to endotracheal tube cuff). Secondary measured outcomes: intra-operative cardiovascular drug use; time to follow command before extubation; protective airway reflex recovery time after extubation. Protective airway reflex test recovery was performed at predetermined time intervals (2, 6, 14, 22 and 30 minutes) from the time to follow a standard command until the first demonstrated ability to swallow 20 ml of water in an upright position.Post-anesthesia care unit recovery data were also recorded: Ramsay sedation scale; vital signs, post-operative pain; morphine consumption.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
December 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Federal University of Minas Gerais
Responsible Party
Principal Investigator
Principal Investigator

Renato Santiago Gomez

Head of surgery department of the Medical School of the Federal University of Minas Gerais

Federal University of Minas Gerais

Eligibility Criteria

Inclusion Criteria

  • Female patients over 18 years old classified by the American Society of Anesthesiologists as physical status I or II, undergoing elective breast surgery with general anesthesia.

Exclusion Criteria

  • History of: illegal drug and alcohol abuse
  • Pregnancy on course or suspicion of
  • Neuromuscular disorders
  • Cerebral vascular disease
  • Dysphagia
  • Dysphonia
  • Gastroesophageal reflux disease
  • Previous larynx and/or upper gastrointestinal tract surgery
  • Allergy to any drug to be used and malignant hyperthermia.
  • Patients who develop hemodynamic instability in the surgery and need blood transfusion were excluded from the study.

Arms & Interventions

REM-PRO

Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.

Intervention: Propofol

REM-DES

Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.

Intervention: Desflurane

Outcomes

Primary Outcomes

Extubation Time

Time Frame: Time from anesthetic discontinuation to endotracheal tube cuff deflation

Time from anesthetic discontinuation to endotracheal tube cuff deflation

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