Awakening in Spine Surgery: A Comparison Between Clinical Signs and Bispectral Index

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Awakening in Spine Surgery Patients Having Neurophysiologic Monitoring: A Comparison Study Between Clinical Signs and Bispectral Index (BIS) Guided Target Controlled Infusion(TCI) of Propofol

Conditions
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Spine Diseases

Intervention / Treatment
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* Device: bispectral index
* Drug: Target controlled infusion of propofol
* Drug: Fentanyl
* Drug: Atracurium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bispectral index/TCI propofol/fentanyl<br>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. | Device: bispectral index<br>* Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia.<br>Drug: Target controlled infusion of propofol<br>* TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups<br>* Other names: TCI propofol;Drug: Fentanyl<br>* Fentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic.<br>Drug: Atracurium<br>* Atracurium 0.6 mg/kg is used for endotracheal intubation<br>* Other names: Tracrium;|
| Placebo Comparator: clinical signs/TCI propofol/fentanyl<br>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. | Drug: Target controlled infusion of propofol<br>* TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups<br>* Other names: TCI propofol;Drug: Fentanyl<br>* Fentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic.<br>Drug: Atracurium<br>* Atracurium 0.6 mg/kg is used for endotracheal intubation<br>* Other names: Tracrium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation Time | Awakening time from finished operation to endotracheal extubation. | 4 hr | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Awakening time, Bispectral index, clinical signs, neurophysiologic monitoring, spine surgery