The Effect of Scalp Block on Surgical Pleth Index(SPI) During a Mayfield Head-holder Insertion

Phase 4

• Conditions: Pain
• Interventions: Procedure: a scalp block

• Registration Number: NCT02916264
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-07
• Status Verified: 2016-09
• Study First Submitted: 2016-09-25
• Study First Submitted QC: 2016-09-26
• Last Update Submitted: 2016-09-26
• Study First Posted: 2016-09-27
• Last Update Posted: 2016-09-27
• Primary Completion: 2017-01
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a scalp block	a scalp block	A standard scalp block ,with 0.5% bupivacaine total dose \< 3 mg/kg, is performed by an anesthesiologist.

Primary Outcome Measures

Name	Time	Method
the change of SPI from baseline	30 minutes

Trial Locations

Locations (1)

Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand