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Nicardipine vs Esmolol Craniotomy Emergence

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ClinicalTrials.gov Identifier: NCT01951950
Recruitment Status : Completed
First Posted : September 27, 2013
Results First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
John Bebawy, Northwestern University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Brain Tumors Drug: Nicardipine Drug: Esmolol Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nicardipine Versus Esmolol for Management of Emergence Hypertension After Craniotomy
Study Start Date : September 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


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.
Drug: Nicardipine
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.
Drug: Esmolol



Primary Outcome Measures :
  1. Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg [ Time Frame: 1 hour postoperatively ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951950


Locations
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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: John F Bebawy, MD Northwestern University

Publications:
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Responsible Party: John Bebawy, Assistant Professor of Anesthesiology & Neurological Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01951950    
Other Study ID Numbers: STU00083793
First Posted: September 27, 2013    Key Record Dates
Results First Posted: August 29, 2014
Last Update Posted: August 29, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nicardipine
Esmolol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents