Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.|
- Intracranial pressure control [ Time Frame: along intensive care unit stay ] [ Designated as safety issue: No ]
- Hypotension (Mean arterial blood pressure<80 mmHg) [ Time Frame: during barbiturate treatment ] [ Designated as safety issue: Yes ]
- Infection [ Time Frame: during barbiturate treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2002|
|Study Completion Date:||December 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
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)
|Son Dureta Hospital|
|Palma, Balearic Island, Spain, 07014|
|Principal Investigator:||Jon Perez, MD||Son Dureta Hospital|