Clinical trial NCT02430389: Effect of Remifentanil on Hemodynamic Stability During Placement of a Mayfield Head Fixation Device for Craniotomy
Official title: Effect of Remifentanil Administration on Hemodynamic Stability During Placement of a Mayfield Head Fixation Device for Craniotomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Keywords: hemodynamic stability
remifentanil
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Mean Arterial Blood Pressure After Head Fixation
timeFrame: Ten minute window after head fixation
Secondary outcomes:
measure: Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations
timeFrame: 10 minute window after head fixation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Laura Hemmer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1097/00000539-199612000-00022.
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.
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. doi: 10.1097/00008506-199904000-00002.
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. No abstract available.
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. doi: 10.1097/00000539-199706000-00022.
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. doi: 10.1097/00008506-200001000-00004.