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

Federal University of Minas Gerais

Status and phase: Completed; Phase 4

Conditions: Delayed Emergence From Anesthesia

Treatments: Drug: Propofol; Drug: Desflurane

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02631525

CAAE - 31820014.8.0000.5149

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

REM-PRO

Active Comparator group

Description:

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

Treatment:

Drug: Propofol

REM-DES

Active Comparator group

Description:

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

Treatment:

Drug: Desflurane