Delayed Emergence From Anesthesia
Conditions
Keywords
Airway extubation, Anesthesia Recovery Period, Desflurane, Propofol, Intravenous anesthesia, Balanced Anesthesia
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.
Interventions
DRUGDesflurane
Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring
DRUGPropofol
Total intravenous anesthesia based on propofol
Sponsors
Baxter Healthcare Corporation
Medtronic - MITG
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extubation Time | Time from anesthetic discontinuation to endotracheal tube cuff deflation | Time from anesthetic discontinuation to endotracheal tube cuff deflation |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| REM-PRO Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.
Propofol: Total intravenous anesthesia based on propofol | 20 |
| REM-DES Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.
Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | REM-PRO | REM-DES | Total |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 15 | 46 years STANDARD_DEVIATION 11 | 50 years STANDARD_DEVIATION 14 |
| Region of Enrollment Brazil | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
Extubation Time
Time from anesthetic discontinuation to endotracheal tube cuff deflation
Time frame: Time from anesthetic discontinuation to endotracheal tube cuff deflation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| REM-PRO | Extubation Time | 9.5 minutes |
| REM-DES | Extubation Time | 6.2 minutes |