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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Delayed Emergence From Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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REM-PRO

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Total intravenous anesthesia based on propofol

REM-DES

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

Group Type ACTIVE_COMPARATOR

Desflurane

Intervention Type DRUG

Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring

Interventions

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Desflurane

Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring

Intervention Type DRUG

Propofol

Total intravenous anesthesia based on propofol

Intervention Type DRUG

Other Intervention Names

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Diprivan

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No