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Clinical Trials/NCT02430389
NCT02430389
Terminated
Not Applicable

Effect of Remifentanil Administration on Hemodynamic Stability During Placement of a Mayfield Head Fixation Device for Craniotomy

Northwestern University1 site in 1 country20 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
Remifentanil
Conditions
Surgery
Sponsor
Northwestern University
Enrollment
20
Locations
1
Primary Endpoint
Mean Arterial Blood Pressure After Head Fixation
Status
Terminated
Last Updated
10 years ago

Overview

Brief Summary

To identify a better method using a combination of routine anesthetic drugs to improve hemodynamic stability during Mayfield head pinning for craniotomy surgery.

Detailed Description

A randomized, placebo-controlled, double-blinded comparative effectiveness study to test hypothesis that addition of remifentanil bolus to a standard anesthetic drug regimen will better attenuate the hemodynamic response to the noxious stimulus of Mayfield head pin insertion than the standard anesthetic drug regimen.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
December 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laura Hemmer

Assistant Professor of Anesthesiology and Neurological Surgery

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • Adult non-pregnant patients
  • undergoing general anesthesia for a craniotomy
  • requiring a Mayfield head fixation device.

Exclusion Criteria

  • Patients under 18 years of age,
  • non-English speaking,
  • pregnancy,
  • opioid tolerance,
  • illegal drug use or alcohol abuse.

Arms & Interventions

Remifentanil

Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).

Intervention: Remifentanil

Normal Saline

Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).

Intervention: Normal Saline

Outcomes

Primary Outcomes

Mean Arterial Blood Pressure After Head Fixation

Time Frame: Ten minute window after head fixation

Secondary Outcomes

  • Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations(10 minute window after head fixation)

Study Sites (1)

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