- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01951950
Nicardipine vs Esmolol Craniotomy Emergence
Nicardipine Versus Esmolol for Management of Emergence Hypertension After Craniotomy
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.
Study Overview
Detailed Description
Emergence hypertension following craniotomy is a well-described, albeit poorly understood, phenomenon. Strict control of blood pressure is of utmost importance during and after neurosurgical procedures; failure to prevent acute rises in arterial blood pressure places patients at increased risk of intracranial bleeding, cerebral edema, increased intracranial pressure, and prolonged hospital stays. Emergence hypertension after craniotomy seems to be the result of an acute and transient increase in catecholamine release, peripheral vasoconstriction, and reduced baroreceptor sensitivity. Prior investigations have demonstrated that treatment with antihypertensive agents is required in 60 to 90% of neurosurgical patients postoperatively. Given the common occurrence of emergence hypertension after craniotomy and the increased risk of potentially devastating events that may occur in the setting of acute increases in arterial blood pressure, it is important to identify how best to manage these hemodynamic changes.
An ideal drug for the management of emergence hypertension would be a short-acting, parenteral drug that is easily and rapidly titratable. Medications commonly utilized include nicardipine, labetolol, and esmolol. When given as a bolus, nicardipine, a calcium channel blocker, demonstrates a maximal response in <2 minutes and a mean half-life of approximately 40 minutes. Nicardipine is also frequently administered as an infusion; however, time to onset is increased if no bolus is administered and duration of action may be 4-6 hours after prolonged infusion. Labetolol, a non-selective beta-blocker, demonstrates onset in 10-20 seconds with peak activity at 5 minutes. Esmolol is an ultra-short-acting, B1-beta-blocker that has rapid onset and is quickly metabolized by nonspecific red blood cell esterases; however, esmolol primarily results in decreased heart rate and demonstrates less effect on blood pressure.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nicardipine
Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr.
Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr.
If systolic blood pressure (SBP) is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication "failure" will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered.
Infusions may be titrated down if SBP decreases below 90 mmHg.
|
|
Active Comparator: Esmolol
Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min.
Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min.
If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication "failure" will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered.
Infusions may be titrated down if SBP decreases below 90 mmHg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg
Time Frame: 1 hour postoperatively
|
1 hour postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John F Bebawy, MD, Northwestern University
Publications and helpful links
General Publications
- 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.
- 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.
- 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. doi: 10.1097/00000539-200010000-00024.
- 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.
- 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. doi: 10.1053/j.jvca.2006.08.005. Epub 2006 Oct 24.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Brain Neoplasms
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Adrenergic beta-1 Receptor Antagonists
- Esmolol
- Nicardipine
Other Study ID Numbers
- STU00083793
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Tumors
-
University of FloridaCompletedCentral Nervous System TumorsUnited States
-
Children's Hospital Los AngelesUnknownBrain and Central Nervous System TumorsUnited States, Canada, Australia, Switzerland, New Zealand
-
St. Jude Children's Research HospitalCompletedBrain Tumors | Central Nervous System TumorsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedBrain Tumors | Central Nervous System TumorsUnited States, Australia, Canada
-
Emory UniversityNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Abramson Cancer Center of the University of PennsylvaniaNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Duke UniversityNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
M.D. Anderson Cancer CenterTerminatedBrain Tumors | Central Nervous System TumorsUnited States
-
Pediatric Brain Tumor ConsortiumNational Cancer Institute (NCI)CompletedVNP40101M in Treating Young Patients With Recurrent, Progressive, or Refractory Primary Brain TumorsBrain and Central Nervous System TumorsUnited States
-
Children's Hospital Medical Center, CincinnatiTerminatedSolid Tumors | Brain TumorsUnited States
Clinical Trials on Nicardipine
-
University of MinnesotaMedical University of South Carolina; Johns Hopkins University; National Institute... and other collaboratorsTerminatedIntracerebral HemorrhageUnited States, Taiwan, Korea, Republic of, Germany, Japan, Canada, China
-
University of MinnesotaNational Institute of Neurological Disorders and Stroke (NINDS)CompletedStroke | Hypertension | Intracerebral HemorrhageUnited States
-
Astellas Pharma China, Inc.CompletedHypertension Emergency | End-organ DamageChina
-
University of Illinois at ChicagoCompletedSubarachnoid Hemorrhage | Intracerebral HemorrhageUnited States
-
The Cleveland ClinicEKR Therapeutics, IncCompletedHypertensive UrgencyUnited States
-
The Medicines CompanyCompletedHypertensionUnited States
-
The Affiliated Hospital Of Guizhou Medical UniversityNot yet recruitingAneurysmal Subarachnoid Hemorrhage | Vasospasm
-
University of FloridaTerminated
-
Yonsei UniversityActive, not recruitingIschemic StrokeKorea, Republic of
-
Peng Roc Chen, MDYale University; Northwell Health; University of Michigan; University of Illinois... and other collaboratorsRecruiting