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Completed

NCT Number: NCT02631525

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Desflurane

Drug

Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring

Propofol

Drug

Total intravenous anesthesia based on propofol

Other names: Diprivan

Primary outcomes

  1. Extubation Time

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

    Time from anesthetic discontinuation to endotracheal tube cuff deflation

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Baxter Healthcare Corporation
  • Medtronic - MITG

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 16, 2015
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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