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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
Sponsor:
Information provided by (Responsible Party):
Sirivimol Punjasawadwong, Chiang Mai University

Brief Summary:
It is a randomized control trial to compare the surgical plethysmographic index (SPI) response during a Mayfield head-holder insertion in neurosurgical patients who receive a scalp block versus those who do not receive the scalp block after induction of anesthesia with propofol with fentanyl and intubation with cis-atracurium.

Condition or disease Intervention/treatment Phase
Pain Procedure: a scalp block Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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,



Primary Outcome Measures :
  1. the change of SPI from baseline [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients will receive a Mayfield head-holder insertion for supratentorial craniotomy

Exclusion Criteria:

  • History of chronic hypertension, Diabetes mellitus (DM), coronary heart diseases
  • Receiving beta blockers
  • BMI > 30
  • Coagulopathy
  • severe liver and renal diseases

Information from the National Library of Medicine

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


Contacts
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Contact: Sirivimol Punjasawadwong, MD +6653935522 siriwimol@gmail.com
Contact: Sirvimol Punjasawadwong, MD +6653935522 siriwimol@gmail.com

Locations
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Thailand
Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University Recruiting
Chiang Mai, Thailand, 50200
Contact: Yodying Punjasawadwong, MD, MMed.Sc.    +6653935522    ypunjasa@gmail.com   
Contact: Yodying Punjasawadwong, MD, MMed.Sc    +6653935522    ypunjasa@gmail.com   
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Sirivimol Punjasawadwong, MD Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University

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Responsible Party: Sirivimol Punjasawadwong, Principal Investigator, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02916264    
Other Study ID Numbers: 03457
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sirivimol Punjasawadwong, Chiang Mai University:
scalp block, surgical peth index