Brain Tumors Clinical Trial
Official title:
Nicardipine Versus Esmolol for Management of Emergence Hypertension After Craniotomy
Verified date | August 2014 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Emergence hypertension is a common occurrence in patients emerging from general anesthesia.
This elevation of arterial pressure is particularly concerning in patients undergoing
craniotomy due to increased risk of morbidity and mortality in patients with altered
intracranial elastance. Thus, identifying better methods to attenuate the hemodynamic
changes associated with emergence from anesthesia can improve patient safety, especially in
the neurosurgical patient.
Study Hypothesis: Nicardipine is more effective than esmolol as a sole agent in maintaining
blood pressure within goal range in the setting of emergence hypertension after craniotomy.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult - non-pregnant patients - (age = 18 years) - undergoing general anesthesia for elective supratentorial, infratentorial, or transsphenoidal craniotomy Exclusion Criteria: - Patients under 18 years of age - non-English speaking, pregnancy - emergent craniotomy (including trauma) - awake craniotomy - active 3 vessel coronary artery disease or left main coronary artery disease - advanced heart block - severe aortic stenosis - chronic renal failure - known or suspected allergy or intolerance to a study drug or its components |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Northwestern Memorial Hospital | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21. doi: 10.1213/ane.0b013e31818240db. — View Citation
Bekker A, Didehvar S, Kim S, Golfinos JG, Parker E, Sapson A, Haile M, Kline R, Lee M. Efficacy of clevidipine in controlling perioperative hypertension in neurosurgical patients: initial single-center experience. J Neurosurg Anesthesiol. 2010 Oct;22(4):330-5. doi: 10.1097/ANA.0b013e3181e3077b. — View Citation
Bilotta F, Lam AM, Doronzio A, Cuzzone V, Delfini R, Rosa G. Esmolol blunts postoperative hemodynamic changes after propofol-remifentanil total intravenous fast-track neuroanesthesia for intracranial surgery. J Clin Anesth. 2008 Sep;20(6):426-30. doi: 10.1016/j.jclinane.2008.04.006. — View Citation
Kovac AL, Masiongale A. Comparison of nicardipine versus esmolol in attenuating the hemodynamic responses to anesthesia emergence and extubation. J Cardiothorac Vasc Anesth. 2007 Feb;21(1):45-50. Epub 2006 Oct 24. — View Citation
Kross RA, Ferri E, Leung D, Pratila M, Broad C, Veronesi M, Melendez JA. A comparative study between a calcium channel blocker (Nicardipine) and a combined alpha-beta-blocker (Labetalol) for the control of emergence hypertension during craniotomy for tumor surgery. Anesth Analg. 2000 Oct;91(4):904-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg | 1 hour postoperatively | No |
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