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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02430389
• Other study ID #: STU00007835
• Status: Terminated
• Phase: N/A
• First received: April 25, 2015
• Last updated: June 25, 2015
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgery

Intervention

Drug:
• Remifentanil
Ninety seconds before pinning, an IV bolus of 10 mL of remifentanil (0.7 µg•kg-1 based on ideal body weight) will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered
• Normal Saline
Ninety seconds before pinning, an IV bolus of 10 mL of normal saline will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Cole CD, Gottfried ON, Gupta DK, Couldwell WT. Total intravenous anesthesia: advantages for intracranial surgery. Neurosurgery. 2007 Nov;61(5 Suppl 2):369-77; discussion 377-8. doi: 10.1227/01.neu.0000303996.74526.30. Review. — View Citation

Coles JP, Leary TS, Monteiro JN, Brazier P, Summors A, Doyle P, Matta BF, Gupta AK. Propofol anesthesia for craniotomy: a double-blind comparison of remifentanil, alfentanil, and fentanyl. J Neurosurg Anesthesiol. 2000 Jan;12(1):15-20. — View Citation

Colley PS, Dunn R. Prevention of blood pressure response to skull-pin head holder by local anesthesia. Anesth Analg. 1979 May-Jun;58(3):241-3. — View Citation

Gazoni FM, Pouratian N, Nemergut EC. Effect of ropivacaine skull block on perioperative outcomes in patients with supratentorial brain tumors and comparison with remifentanil: a pilot study. J Neurosurg. 2008 Jul;109(1):44-9. doi: 10.3171/JNS/2008/109/7/0044. — View Citation

Hans P, Brichant JF, Dewandre PY, Born JD, Lamy M. Effects of two calculated plasma sufentanil concentrations on the hemodynamic and bispectral index responses to Mayfield head holder application. J Neurosurg Anesthesiol. 1999 Apr;11(2):81-5. — View Citation

Jamali S, Archer D, Ravussin P, Bonnafous M, David P, Ecoffey C. The effect of skull-pin insertion on cerebrospinal fluid pressure and cerebral perfusion pressure: influence of sufentanil and fentanyl. Anesth Analg. 1997 Jun;84(6):1292-6. — View Citation

Pinosky ML, Fishman RL, Reeves ST, Harvey SC, Patel S, Palesch Y, Dorman BH. The effect of bupivacaine skull block on the hemodynamic response to craniotomy. Anesth Analg. 1996 Dec;83(6):1256-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Arterial Blood Pressure After Head Fixation		Ten minute window after head fixation	Yes
Secondary	Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations		10 minute window after head fixation	No