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

Hospital Universitari Son Dureta

Status and phase

Terminated

Phase 3

Conditions

Traumatic Brain Injury

Treatments

Drug: Pentobarbital

Drug: thiopental

Study type

Interventional

Funder types

Other

Identifiers

NCT00622570

PI 02/0642

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

15 to 75 years old

Volunteers

No Healthy Volunteers

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