The Effect of Scalp Block on Surgical Pleth Index(SPI) During a Mayfield Head-holder Insertion
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|ClinicalTrials.gov Identifier: NCT02916264|
Recruitment Status : Unknown
Verified September 2016 by Sirivimol Punjasawadwong, Chiang Mai University.
Recruitment status was: Recruiting
First Posted : September 27, 2016
Last Update Posted : September 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pain||Procedure: a scalp block||Phase 4|
Study design is a randomized controlled trial Participants include adult neurosurgical patients scheduled to have a Mayfield head-holder insertion for supratentorial craniotomy Intervention is a scalp block prior to a Mayfield head holder insertion. Comparison is 'no scalp block' Outcome is surgical plethysmographic index (SPI) responses during/after a Mayfield head holder insertion Sample size includes 30 cases (15 cases per arm)
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Scalp Block on Surgical Pleth Index(SPI) During a Mayfield Head-holder Insertion in Neurosurgery : a Randomized Control Trial|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||March 2017|
Active Comparator: a scalp block
A standard scalp block ,with 0.5% bupivacaine total dose < 3 mg/kg, is performed by an anesthesiologist.
Procedure: 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 Intervention: no scalp block
An anesthesiology will pretend to perform the scalp block,
- the change of SPI from baseline [ Time Frame: 30 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916264
|Contact: Sirivimol Punjasawadwong, MDemail@example.com|
|Contact: Sirvimol Punjasawadwong, MDfirstname.lastname@example.org|
|Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University||Recruiting|
|Chiang Mai, Thailand, 50200|
|Contact: Yodying Punjasawadwong, MD, MMed.Sc. +6653935522 email@example.com|
|Contact: Yodying Punjasawadwong, MD, MMed.Sc +6653935522 firstname.lastname@example.org|
|Principal Investigator:||Sirivimol Punjasawadwong, MD||Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University|