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

Overview

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.

Full Title of Study: “Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 2007

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: 1
    • Pentobarbital
  • Active Comparator: 2
    • thiopental

Clinical Trial Outcome Measures

Primary Measures

  • Intracranial pressure control
    • Time Frame: along intensive care unit stay

Secondary Measures

  • Hypotension (Mean arterial blood pressure<80 mmHg)
    • Time Frame: during barbiturate treatment
  • Infection
    • Time Frame: during barbiturate treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitari Son Dureta
  • Collaborator
    • Fondo de Investigacion Sanitaria
  • Provider of Information About this Clinical Study
    • Dr. Jon Pérez Bárcena, Hospital Son Dureta
  • Overall Official(s)
    • Jon Perez, MD, Principal Investigator, Son Dureta Hospital

Citations Reporting on Results

Pérez-Bárcena J, Barceló B, Homar J, Abadal JM, Molina FJ, de la Peña A, Sahuquillo J, Ibáñez J. [Comparison of the effectiveness of pentobarbital and thiopental in patients with refractory intracranial hypertension. Preliminary report of 20 patients]. Neurocirugia (Astur). 2005 Feb;16(1):5-12; discussion 12-3. Spanish.

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