NCT00622570

Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension

Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Hospital Universitari Son Dureta · Academic / Other
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Pentobarbital	10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h
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

Timeline

• Start date: 2002-05-01
• Primary completion: 2007-07-01
• Completion: 2007-12-01
• First posted: 2008-02-25
• Last updated: 2008-02-25

Locations

1 site across 1 country: Spain