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A priori hypothesis confirmed with interim analysis.
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To identify a better method using a combination of routine anesthetic drugs to improve hemodynamic stability during Mayfield head pinning for craniotomy surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Blood Pressure After Head Fixation | Ten minute window after head fixation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations | 10 minute window after head fixation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Hemmer, M.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18091252 | Background | 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. | |
| 8942596 | 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. |
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Northwestern Memorial Hospital Ambulatory Surgery Unit or equivalent location where preoperative anesthesia evaluation occurring.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). 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. |
| FG001 | 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). Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Arterial Blood Pressure After Head Fixation | Posted | Mean | Standard Deviation | mm Hg | Ten minute window after head fixation |
|
10 minutes post Mayfield head-pinning.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemodynamic perturbation | Cardiac disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura B. Hemmer, M.D. | Northwester University | 312-695-0061 | l-hemmer@northwestern.edu |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 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 |
|
| 18590431 | 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. |
| 10213433 | 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. |
| 572163 | 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. |
| 9174309 | 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. |
| 10636615 | 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. |
| BG001 | 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). Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations | Posted | Number | participants | 10 minute window after head fixation |
|
|
|
|
| 0 |
| 10 |
| 5 |
| 10 |
| EG001 | 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). Placebo | 0 | 10 | 8 | 10 |
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |