The Effect of Scalp Block on Surgical Pleth Index(SPI) During a Mayfield Head-holder Insertion
NCT ID: NCT02916264
Last Updated: 2016-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2016-07-31
2017-03-31
Brief Summary
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Detailed Description
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The eligible neurosurgical patients will be randomly allocated, by a concealed randomization process, to receive or not to receive a scalp block after induction and intubation with propofol/fentanyl and cisatracurium. Surgical plethysmographic index, direct arterial blood pressure, heart rate (EEG), End tidal Carbondioxide, Bispectral/entropy (40-60) will be recorded every one minute before/after induction and intubation, before/after the scalp block, and before/after the Mayfield head-holder insertion. The Mayfield head-holder insertion will be performed by a neurosurgeon who will be blinded to the allocated groups.
Data analysis is performed to compare the change of SPI during and after the Mayfield head-holder insertion from the baseline in both groups by using repeated measure ANOVA at the significant level of 0.05.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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a scalp block
A standard scalp block ,with 0.5% bupivacaine total dose \< 3 mg/kg, is performed by an anesthesiologist.
a scalp block
Bilateral blocks of six nerves: ie. supraorbital and supraorbital nerves (V1), zygomaticotemporal nerves (V2) , auriculotemporal nerves , greater occipital nerves, and lesser occipital nerves will be performed by a well trained anesthesiologist with 0.5% bupivacaine not exceeding 3 mg/kg
no scalp block
An anesthesiology will pretend to perform the scalp block,
No interventions assigned to this group
Interventions
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a scalp block
Bilateral blocks of six nerves: ie. supraorbital and supraorbital nerves (V1), zygomaticotemporal nerves (V2) , auriculotemporal nerves , greater occipital nerves, and lesser occipital nerves will be performed by a well trained anesthesiologist with 0.5% bupivacaine not exceeding 3 mg/kg
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Receiving beta blockers
* BMI \> 30
* Coagulopathy
* severe liver and renal diseases
18 Years
80 Years
ALL
No
Sponsors
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Chiang Mai University
OTHER
Responsible Party
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Sirivimol Punjasawadwong
Principal Investigator
Principal Investigators
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Sirivimol Punjasawadwong, MD
Role: PRINCIPAL_INVESTIGATOR
Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University
Locations
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Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University
Chiang Mai, Chiang Mai, Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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03457
Identifier Type: -
Identifier Source: org_study_id
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