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

Not Applicable

Terminated

• Conditions: Surgery
• Interventions: Drug: Normal Saline; Drug: Remifentanil

• Registration Number: NCT02430389
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-11
• Study Completion: 2014-12
• Study First Submitted: 2015-04-25
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-04-30
• Results First Submitted: 2015-05-21
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-25
• Last Update Submitted: 2015-06-25
• Results First Posted: 2015-06-30
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	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).
Remifentanil	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).

Primary Outcome Measures

Name	Time	Method
Mean Arterial Blood Pressure After Head Fixation	Ten minute window after head fixation

Secondary Outcome Measures

Name	Time	Method
Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations	10 minute window after head fixation

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States