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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bispectral index/TCI propofol/fentanyl | Active Comparator | Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation. Fentanyl is used for analgesia and atracurium is used for tracheal intubation. |
|
| clinical signs/TCI propofol/fentanyl | Placebo Comparator | Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol. Fentanyl is used for analgesia and atracurium is used for tracheal intubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bispectral index | Device | Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extubation Time | Awakening time from finished operation to endotracheal extubation. | 4 hr |
| Measure | Description | Time Frame |
|---|---|---|
| Total Propofol Dosage | total propofol dosage = propofol dose from start to end of the operation | From start anesthesia to finish operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manee Raksakietisak, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahidol University, siriraj hospital | Bangkok | 10700 | Thailand |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bispectral Index | Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation. |
| FG001 | Clinical Signs | Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
40 patients met the inclusion criteria; however, three patients in each group were discontinued from the study due to protocol violation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bispectral Index | Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation. |
| BG001 | Clinical Signs | Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Extubation Time | Awakening time from finished operation to endotracheal extubation. | Posted | Mean | Standard Deviation | min | 4 hr |
|
|
From start anesthesia to 24 hr after operation.
The cardiovascular, respiratory, neurological or other complications during the intraoperative period are recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bispectral Index | Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department of Anesthesiology, Siriraj Hospital | Mahidol University | 66-2-41979889 | 501 | manee95@hotmail.com |
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D056805 | Consciousness Monitors |
| D005283 | Fentanyl |
| D001279 | Atracurium |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Target controlled infusion of propofol | Drug | TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups |
|
|
| Fentanyl | Drug | Fentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic. |
|
| Atracurium | Drug | Atracurium 0.6 mg/kg is used for endotracheal intubation |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight | Mean | Standard Deviation | kg |
|
| Participants |
|
|
| Secondary | Total Propofol Dosage | total propofol dosage = propofol dose from start to end of the operation | Posted | Mean | Standard Deviation | mg | From start anesthesia to finish operation |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Clinical Signs | Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D006571 |
| Heterocyclic Compounds |
| D044182 | Benzylisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |