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Clinical Trials/NCT02916264
NCT02916264UnknownPhase 4

The Effect of Scalp Block on Surgical Pleth Index(SPI) During a Mayfield Head-holder Insertion in Neurosurgery : a Randomized Control Trial

Chiang Mai University2 sites in 1 country30 target enrollmentStarted: July 2016Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Enrollment
30
Locations
2
Primary Endpoint
the change of SPI from baseline

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

the change of SPI from baseline

Time Frame: 30 minutes

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sirivimol Punjasawadwong

Principal Investigator

Chiang Mai University

Study Sites (2)

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