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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
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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 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Traumatic brain injury, barbiturate coma |
Anesthetics, Intravenous Craniocerebral Trauma Neurotransmitter Agents Thiopental Adjuvants, Immunologic Pseudotumor Cerebri Vascular Diseases Wounds and Injuries Central Nervous System Depressants Anesthetics Central Nervous System Diseases |
Disorders of Environmental Origin Trauma, Nervous System Brain Diseases Intracranial Hypertension Coma Pentobarbital Anesthetics, General Hypnotics and Sedatives Brain Injuries Anticonvulsants Hypertension |
Craniocerebral Trauma Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Thiopental GABA Modulators Physiological Effects of Drugs Anesthetics Disorders of Environmental Origin Brain Diseases Intracranial Hypertension Pentobarbital Therapeutic Uses Hypnotics and Sedatives Cardiovascular Diseases Brain Injuries |
Anesthetics, Intravenous Nervous System Diseases Wounds and Injuries Vascular Diseases Pseudotumor Cerebri Central Nervous System Diseases Central Nervous System Depressants Trauma, Nervous System Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General GABA Agents Central Nervous System Agents Anticonvulsants Hypertension |