Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension
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|ClinicalTrials.gov Identifier: NCT00622570|
Recruitment Status : Terminated (Slowly recruitment rate. Intermediate analysis)
First Posted : February 25, 2008
Last Update Posted : February 25, 2008
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 or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Drug: Pentobarbital Drug: thiopental||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.|
|Study Start Date :||May 2002|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||December 2007|
10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h
Other Name: Nembutal(r)
Active Comparator: 2
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
Other Name: PENTOTHAL(R)
- Intracranial pressure control [ Time Frame: along intensive care unit stay ]
- Hypotension (Mean arterial blood pressure<80 mmHg) [ Time Frame: during barbiturate treatment ]
- Infection [ Time Frame: during barbiturate treatment ]
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): NCT00622570
|Son Dureta Hospital|
|Palma, Balearic Island, Spain, 07014|
|Principal Investigator:||Jon Perez, MD||Son Dureta Hospital|