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Sponsors and Collaborators: |
Hospital Universitari Son Dureta Fondo de Investigacion Sanitaria |
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Information provided by: | Hospital Universitari Son Dureta |
ClinicalTrials.gov Identifier: | NCT00622570 |
Objective: to assess the effectiveness of pentobarbital and thiopental to control raised intracranial pressure (ICP), refractory to first level measures, in patients with severe traumatic brain injury.
Material and methods: prospective, randomized open study to compare the effectiveness between two treatments: pentobarbital and thiopental. The patients will be selected from those admitted to the Intensive Care Unit with a severe traumatic brain injury (postresuscitation Glasgow Coma Scale equal or less than 8 points) and raised ICP (ICP>20 mmHg) refractory to first level measures according to the Brain Trauma Foundation guidelines. The adverse effects of both treatments were also collected.
Condition | Intervention | Phase |
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Traumatic Brain Injury |
Drug: Pentobarbital Drug: thiopental |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension. |
Enrollment: | 44 |
Study Start Date: | May 2002 |
Study Completion Date: | December 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pentobarbital
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Drug: Pentobarbital
10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h
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2: Active Comparator
thiopental
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Drug: thiopental
2 mg/kg in bolus; if ICP is not below 20 mmHg then 3 mg/kg in bolus; if ICP is not below 20 mmHg it can be administrated a third bolus of 5 mg/kg. Maintenance: 3 mg/kg/h in perfusion |
Ages Eligible for Study: | 15 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain, Balearic Island | |
Son Dureta Hospital | |
Palma, Balearic Island, Spain, 07014 |
Principal Investigator: | Jon Perez, MD | Son Dureta Hospital |
Responsible Party: | Hospital Son Dureta ( Dr. Jon Pérez Bárcena ) |
Study ID Numbers: | PI 02/0642, IB |
Study First Received: | February 14, 2008 |
Last Updated: | February 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00622570 |
Health Authority: | Spain: Spanish Agency of Medicines |
Traumatic brain injury, barbiturate coma |
Craniocerebral Trauma Thiopental Pseudotumor Cerebri Vascular Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System |
Brain Diseases Intracranial Hypertension Coma Pseudotumor cerebri Pentobarbital Brain Injuries Hypertension |
Anesthetics, Intravenous Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Nervous System Diseases Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pharmacologic Actions |
Adjuvants, Anesthesia Anesthetics, General Therapeutic Uses Hypnotics and Sedatives GABA Agents Cardiovascular Diseases Central Nervous System Agents Anticonvulsants |