Clinical trial NCT02631525: Recovery Profile Comparison Between Remifentanil-propofol or Desflurane Anesthesia Monitored With Bispectral Index.
Official title: A Comparison of Post-operative Recovery Between Remifentanil-propofol and Remifentanil-desflurane Anesthesia Guided by Bispectral Index Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Delayed Emergence From Anesthesia
Keywords: Airway extubation
Anesthesia Recovery Period
Desflurane
Propofol
Intravenous anesthesia
Balanced Anesthesia
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
name: Medtronic - MITG
First posted: 2015-12-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Extubation Time
timeFrame: Time from anesthetic discontinuation to endotracheal tube cuff deflation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor of the Medicine School of the Federal University of Minas Gerais
name: Renato S Gomez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu ZF, Jian GS, Lee MS, Lin C, Chen YF, Chen YW, Huang YS, Cherng CH, Lu CH. An analysis of anesthesia-controlled operating room time after propofol-based total intravenous anesthesia compared with desflurane anesthesia in ophthalmic surgery: a retrospective study. Anesth Analg. 2014 Dec;119(6):1393-406. doi: 10.1213/ANE.0000000000000435.
citation: Mckay RE, Large MJC, Balea MC, Mckay WR. Airway reflexes return more rapidly after desflurane anesthesia than after sevoflurane anesthesia. Anesth Analg. 2005 Mar;100(3):697-700. doi: 10.1213/01.ANE.0000146514.65070.AE.
citation: Wachtel RE, Dexter F, Epstein RH, Ledolter J. Meta-analysis of desflurane and propofol average times and variability in times to extubation and following commands. Can J Anaesth. 2011 Aug;58(8):714-24. doi: 10.1007/s12630-011-9519-1. Epub 2011 Jun 1.
citation: Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.