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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00622570
Recruitment Status : Terminated (Slowly recruitment rate. Intermediate analysis)
First Posted : February 25, 2008
Last Update Posted : February 25, 2008
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Universitari Son Dureta

Brief 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Pentobarbital Drug: thiopental Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.
Study Start Date : May 2002
Actual Primary Completion Date : July 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: Pentobarbital
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
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

Other Name: PENTOTHAL(R)

Primary Outcome Measures :
  1. Intracranial pressure control [ Time Frame: along intensive care unit stay ]

Secondary Outcome Measures :
  1. Hypotension (Mean arterial blood pressure<80 mmHg) [ Time Frame: during barbiturate treatment ]
  2. Infection [ Time Frame: during barbiturate treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00622570

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Son Dureta Hospital
Palma, Balearic Island, Spain, 07014
Sponsors and Collaborators
Hospital Universitari Son Dureta
Fondo de Investigacion Sanitaria
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Principal Investigator: Jon Perez, MD Son Dureta Hospital

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Jon Pérez Bárcena, Hospital Son Dureta Identifier: NCT00622570     History of Changes
Other Study ID Numbers: PI 02/0642
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: February 25, 2008
Last Verified: July 2007

Keywords provided by Hospital Universitari Son Dureta:
Traumatic brain injury, barbiturate coma

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Intracranial Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia