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

NCT02430389 | Terminated Results

• 1 other identifier: STU00007835
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

hemodynamic stability; remifentanil

Outcome Measures

Primary Outcomes (1)

• Mean Arterial Blood Pressure After Head Fixation

  Ten minute window after head fixation

Secondary Outcomes (1)

• Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations

  10 minute window after head fixation

Study Arms (2)

Remifentanil

EXPERIMENTAL

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).

Drug: Remifentanil

Normal Saline

PLACEBO COMPARATOR

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).

Drug: Normal Saline

Interventions

Remifentanil DRUG

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

Also known as: Ultiva

Remifentanil

Normal Saline DRUG

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

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult non-pregnant patients
• undergoing general anesthesia for a craniotomy
• requiring a Mayfield head fixation device.

You may not qualify if:

• Patients under 18 years of age,
• non-English speaking,
• pregnancy,
• opioid tolerance,
• illegal drug use or alcohol abuse.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related 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.

  PMID: 18091252 BACKGROUND

• 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.

  PMID: 8942596 BACKGROUND

• 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.

  PMID: 18590431 BACKGROUND

• 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.

  PMID: 10213433 BACKGROUND

• 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.

  PMID: 572163 BACKGROUND

• 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.

  PMID: 9174309 BACKGROUND

• 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.

  PMID: 10636615 BACKGROUND

MeSH Terms

Interventions

Remifentanil; Saline Solution

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Study terminated early due to interim analysis with patients in placebo group having substantially higher systemic HTN requiring rescue meds compared to study drug group. Another limitation is difficulty defining baseline BP preoperatively.

Results Point of Contact

• Title: Laura B. Hemmer, M.D.
• Organization: Northwester University

l-hemmer@northwestern.edu

312-695-0061

Study Officials

• Laura Hemmer, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Neurological Surgery

Study Record Dates

• First Submitted: April 25, 2015
• First Posted: April 30, 2015
• Study Start: July 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2014
• Last Updated: June 30, 2015
• Results First Posted: June 30, 2015

Record last verified: 2015-06

Locations

US (1)