Effect of Remifentanil on Hemodynamic Stability During Placement of a Mayfield Head Fixation Device for Craniotomy
Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Surgery
Intervention: Remifentanil (Drug); Normal Saline (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Northwestern University Official(s) and/or principal investigator(s):
Laura Hemmer, M.D., Principal Investigator, Affiliation: Northwestern University
Summary
To identify a better method using a combination of routine anesthetic drugs to improve
hemodynamic stability during Mayfield head pinning for craniotomy surgery.
Clinical Details
Official title: Effect of Remifentanil Administration on Hemodynamic Stability During Placement of a Mayfield Head Fixation Device for Craniotomy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Mean Arterial Blood Pressure After Head Fixation
Secondary outcome: Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Northwestern Memorial Hospital, Chicago, Illinois 60611, United States
Additional Information
Related publications: 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. 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. 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. 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. 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. 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. 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.
Starting date: July 2012
Last updated: June 25, 2015
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