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

• Sponsor: Northwestern University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02430389
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Drug: Remifentanil; Drug: Normal Saline	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Effect of Remifentanil Administration on Hemodynamic Stability During Placement of a Mayfield Head Fixation Device for Craniotomy
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remifentanil 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; 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; Other Names: Ultiva
Placebo Comparator: Normal Saline 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; 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

Outcome Measures

Primary Outcome Measures

1. Mean Arterial Blood Pressure After Head Fixation [Ten minute window after head fixation]

Secondary Outcome Measures

1. Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations [10 minute window after head fixation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Laura Hemmer, M.D., Northwestern University

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Laura Hemmer, Assistant Professor of Anesthesiology and Neurological Surgery, Northwestern University
• ClinicalTrials.gov Identifier: NCT02430389
• Other Study ID Numbers: STU00007835
• First Posted: Apr 30, 2015
• Last Update Posted: Jun 30, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Laura Hemmer, Assistant Professor of Anesthesiology and Neurological Surgery, Northwestern University: hemodynamic stability; remifentanil
• Additional relevant MeSH terms: Remifentanil

Study Results

Participant Flow

Recruitment Details	Northwestern Memorial Hospital Ambulatory Surgery Unit or equivalent location where preoperative anesthesia evaluation occurring.

Arm/Group Title	Remifentanil	Normal Saline
Arm/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). Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning.	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). Placebo
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Remifentanil	Normal Saline	Total
Arm/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). Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning.	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). Placebo	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.3 (12.2)	51.7 (4.8)	56.5 (10.3)
Sex: Female, Male (Count of Participants)
Female	7 70%	4 40%	11 55%
Male	3 30%	6 60%	9 45%

Outcome Measures

1. Primary Outcome

Title	Mean Arterial Blood Pressure After Head Fixation
Time Frame	Ten minute window after head fixation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Normal Saline
Arm/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). Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning.	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). Placebo
Measure Participants	10	10
Mean (Standard Deviation) [mm Hg]	76 (8)	83 (12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Normal Saline
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.0575
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations
Time Frame	10 minute window after head fixation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remifentanil	Normal Saline
Arm/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). 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	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). 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
Measure Participants	10	10
Number [participants]	5 50%	8 80%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remifentanil, Normal Saline
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.348
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	10 minutes post Mayfield head-pinning.
Adverse Event Reporting Description	In addition, patients were given contact information for study director if they had concerns of an adverse event or other concerns upon conclusion of study/recovery from anesthesia. Assessment of adverse reactions via chart review with need for rescue drug therapy.
Arm/Group Title	Remifentanil		Normal Saline
Arm/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). Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning.		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). Placebo
All Cause Mortality
	Remifentanil		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Remifentanil		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Remifentanil		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/10 (50%)		8/10 (80%)
Cardiac disorders
hemodynamic perturbation	5/10 (50%)	11	8/10 (80%)	31

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.