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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Federal University of Minas Gerais

Current Primary Outcome: Extubation time [ Time Frame: Time from anesthetic discontinuation to endotracheal tube cuff deflation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to follow command (up to 10 minutes) [ Time Frame: time from anesthetics discontinuation to follow a standard command ]
  • Protective airway reflex test recovery [ Time Frame: After patient extubation 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-operative analgesia requirements (up to 90 minutes) [ Time Frame: After patient exits operating room and during his/her stay in the post-anesthesia unit ]
    Dose of morphine in the post-anesthesia unit
  • Intra-operative use of cardiovascular drugs (up to 360 minutes) [ Time Frame: From airway intubation until extubation (During the anesthesia) ]
    Use of cardiovascular drugs during anesthesia
  • Post-anesthesia unit vital signs, sedation, pain score and nausea and vomite score (up to 90 minutes) [ Time Frame: During the post-anesthesia unit stay ]


Original Secondary Outcome: Same as current

Information By: Federal University of Minas Gerais

Dates:
Date Received: December 4, 2015
Date Started: August 2014
Date Completion:
Last Updated: December 11, 2015
Last Verified: December 2015