Spine Diseases
Conditions
Keywords
Awakening time, Bispectral index, clinical signs, neurophysiologic monitoring, spine surgery
Brief summary
BIS is one of several equipments used to monitor depth of anesthesia.Some studies found BIS can reduce total propofol dose when being used with target controlled infusion (TCI).The objective is to compare awakening time after spine surgery between using clinical signs and bispectral index (BIS) guided target controlled infusion(TCI) of propofol in patients having neurophysiologic monitoring.
Detailed description
34 patients undergoing spine surgery will be enrolled and randomly assigned into two groups. We exclude patients who age under 18 and over 80 years, preoperative hemodynamics instability, propofol allergy, receiving drugs interfered with EEG, liver disease, Body Mass Index (BMI) over 30 kg/m2. Before induction the patient will be given 0.9% Sodium Chloride (NaCl) or acetate Ringer solution 7 ml/kg. Standard monitorings are used to all patients. Control group will receive fentanyl 1 mcg/kg and then fentanyl infusion 1 mcg/kg/hr and propofol TCI target 3-7 mcg/ml until asleep and then atracurium 0.5 mg/kg was given to facilitate endotracheal intubation. The patients will be ventilated with air:oxygen 1:1 L. The TCI propofol will be adjusted by clinical monitoring. If the patient has minor movement, the propofol TCI will be increased incrementally to 0.5 mcg/ml higher level but if major movement occurs the dose will be increased to1.0 mcg/ml higher. When hypotension occurs, this will be treated by fluid loading 200 ml in 10 min if it is not improved, then ephedrine or norepinephrine will be given and the TCI dose will be decreased by 0.5 mcg/ml lower level but not lower than 3.0 mcg/ml. Hypertension will be treated by fentanyl bolus 0.5 mcg/kg and increasing TCI dose to 0.5 mcg/ml higher level but not more than 7 mcg/ml. If hypertension persist, the nicardipine or diltiazem will be given. Intervention group receives fentanyl 1 mcg/kg and then fentanyl infusion 1 mcg/kg/hr and propofol by TCI 3-7 mcg/ml until asleep and then atracurium 0.5 mg/kg was given to facilitate endotracheal intubation. The patients will be ventilated with air:oxygen 1:1 L. Propofol will be adjusted by BIS monitoring. If the movement occurs and BIS 40-60, fentanyl 0.5 mcg/kg will be given, BIS \> 60, TCI dose will be increased 0.5 mcg/ml higher level until BIS 40-60. When hypotension occurs, if BIS 40-60, will be treated by load fluid 200 ml in 10 mins, then ephedrine or norepinephrine will be given, If BIS \< 40 the TCI dose will decrease 0.5 mcg/ml but not lower than 3.0 mcg/ml. Hypertension occurs, if BIS \> 60 will be treated by fentanyl bolus 0.5 mcg/kg and TCI dose will be increased 0.5 mcg/ml higher level but not more than 7 mcg/ml if not improved, nicardipine or diltiazem will be given. if BIS 40-60, nicardipine or diltiazem will be given. This outcome measures are extubation time,total propofol dose.
Interventions
Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia.
TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups
Fentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic.
Atracurium 0.6 mg/kg is used for endotracheal intubation
Sponsors
Study design
Eligibility
Inclusion criteria
* spine surgery with neurophysiology monitoring * ASA 1-3 * elective case * cooperate patients * Not receive drugs interfere with EEG
Exclusion criteria
* unstable hemodynamics * liver disease * propofol allergy * BMI \> 30 * complete cord lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extubation Time | 4 hr | Awakening time from finished operation to endotracheal extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Propofol Dosage | From start anesthesia to finish operation | total propofol dosage = propofol dose from start to end of the operation |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bispectral Index Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation. | 17 |
| Clinical Signs Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol. | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | Bispectral Index | Clinical Signs | Total |
|---|---|---|---|
| Age, Continuous | 50.1 years STANDARD_DEVIATION 11.6 | 48.0 years STANDARD_DEVIATION 12.1 | 49.05 years STANDARD_DEVIATION 11.85 |
| Body weight | 62.8 kg STANDARD_DEVIATION 11.8 | 60.4 kg STANDARD_DEVIATION 8.1 | 61.6 kg STANDARD_DEVIATION 9.9 |
| Region of Enrollment Thailand | 17 participants | 17 participants | 34 participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Extubation Time
Awakening time from finished operation to endotracheal extubation.
Time frame: 4 hr
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bispectral Index | Extubation Time | 16.3 min | Standard Deviation 9.7 |
| Clinical Signs | Extubation Time | 16.6 min | Standard Deviation 8.9 |
Total Propofol Dosage
total propofol dosage = propofol dose from start to end of the operation
Time frame: From start anesthesia to finish operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bispectral Index | Total Propofol Dosage | 2,146 mg | Standard Deviation 742 |
| Clinical Signs | Total Propofol Dosage | 2,340 mg | Standard Deviation 839 |