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

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Son Dureta
• Collaborator: Fondo de Investigacion Sanitaria
• Treatments: Pentobarbital; Thiopental

Criteria

Inclusion Criteria:

• Patients with a severe closed head injury and a post-resuscitation Glasgow Coma Scale (GCS) score below or equal to 8

• Age between 15 and 76 years (inclusive)

• High ICP (> 20 mm Hg) refractory to first-tier therapeutic measures according to BTF guidelines (1)

• Hemodynamic stability defined as a systolic blood pressure of at least 100 mm Hg or above at the moment of entering the trial

• Written informed consent obtained from next-of-kin or the patient's legally authorized representative

Exclusion Criteria:

• Previously known ischemic heart failure (Ejection fraction < 35%)

• Pregnancy

• bilateral dilated and unreactive pupils and a GCS of 3

• Intolerance to barbiturates