- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00952081
A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clevidipine, a recently introduced, short-acting, vascular-selective calcium antagonist, could be a potentially useful adjuvant for neurosurgical cases. It decreases arterial blood pressure by reducing systemic vascular resistance with no effect on venous capacitance vessels (7). Clevidipine was successfully used for the treatment of hypertension in cardiac surgical patients (8). However, there is no information available on its efficacy and safety in patients undergoing intracranial surgery.
The perioperative course of patients undergoing intracranial surgery is frequently complicated by acute hypertensive episodes. Acute hypertension in neurosurgical patients is associated with intracranial bleeds and prolonged hospital stay (1). Even with current neuroanesthesia management, hemodynamic stability may be challenging, especially in hypertensive patients. An anesthetic technique that improves perioperative hemodynamics without increasing the incidence of undesirable events (such as increased intracranial pressure, prolonged recovery, etc.) is desirable.
A number of antihypertensive agents are available to treat perioperative hypertension. Labetalol is commonly used to treat hypertensive episodes in patients undergoing craniotomy, but may not be desirable in certain patient populations because of its low potency, a slow onset of peak effect (2), and unpredictability in dose requirements (3). Esmolol is only mildly effective in treating postoperative hypertension. Perioperative use is further complicated by bradycardia and conduction delay. Nicardipine is more effective than esmolol in controlling postoperative hypertension (4). However, it causes a dose-dependent cerebral vasodilation, inhibition of autoregulation, as well as a high incidence of hypotension (as compared to labetalol) (5). Hydralazine may increase intracranial pressure by as much as 100% and is rarely used as the sole agent in treating hypertension in neurosurgical patients (6).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- NYU Langone Medical Center, Department of Anesthesiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 21 or older
- Able to give consent
- No significant laboratory abnormalities
- Undergoing elective surgery for tumor resection or epilepsy focus resection
Exclusion Criteria:
- Patients with acute cardiac ischemia, renal or liver dysfunction, unstable hemodynamic, advanced heart block, or pregnancy defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and in patients with severe aortic stenosis will be excluded.
- Known or suspected allergy to study drug or study drug components,patients with allergies to soybeans, soy products, eggs, or egg products; Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: clevidipine,brain tumor,hypertension
21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
|
Clevidipine (0.5 mg/ml in 20 % lipid solution) will be administered via peripheral vein using syringe pump; drug infusion will be initiated at 5 mg/hr (10ml/h) and titrated to effect up to a maximum rate of 32 mg/hr when SBP exceeds 130 mm Hg.
The anesthesiologist will be allowed to administer the alternative antihypertensive treatment (e.g.
labetalol, hydralazine) after achieving a maximum clevidipine infusion rate.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Primary Endpoint of This Trial is the Proportion of Patients Who Did Not Require Rescue Antihypertensive Medication to Maintain SBP Below 130 mmHg (i.e. Clevidipine is a Sole Antihypertensive Agent Used for Blood Pressure Control)
Time Frame: intraoperatively and 90 min after surgery
|
intraoperatively and 90 min after surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
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
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Epilepsy
- Hypertension
- Brain Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Clevidipine
Other Study ID Numbers
- 08-745
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.
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