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

Information source: Hospital Universitari Son Dureta
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Traumatic Brain Injury

Intervention: Pentobarbital (Drug); thiopental (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Hospital Universitari Son Dureta

Official(s) and/or principal investigator(s):
Jon Perez, MD, Principal Investigator, Affiliation: Son Dureta Hospital


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Intracranial pressure control

Secondary outcome:

Hypotension (Mean arterial blood pressure<80 mmHg)



Minimum age: 15 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

Son Dureta Hospital, Palma, Balearic Island 07014, Spain
Additional Information

Starting date: May 2002
Last updated: February 22, 2008

Page last updated: August 23, 2015

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