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

Northwestern University

Status: Terminated

Conditions: Surgery

Treatments: Drug: Remifentanil; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02430389

STU00007835

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Remifentanil

Experimental group

Description:

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).

Treatment:

Drug: Remifentanil

Normal Saline

Placebo Comparator group

Description:

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).

Treatment:

Drug: Normal Saline