Recovery Profile Comparison Between Remifentanil-propofol or Desflurane Anesthesia Monitored With Bispectral Index.

Phase 4

Completed

• Conditions: Delayed Emergence From Anesthesia
• Interventions: Drug: Desflurane; Drug: Propofol

• Registration Number: NCT02631525
• Lead Sponsor: Federal University of Minas Gerais

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.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Status Verified: 2020-08
• Results First Submitted: 2020-08-11
• Results First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Results First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.
• Patients unable to swallow 20 ml of water in an upright position were also excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REM-DES	Desflurane	Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.
REM-PRO	Propofol	Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.

Primary Outcome Measures

Name	Time	Method
Extubation Time	Time from anesthetic discontinuation to endotracheal tube cuff deflation	Time from anesthetic discontinuation to endotracheal tube cuff deflation