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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00622570

Enrollment

Registered

2008-02-25

Start date

2002-05-31

Completion date

2007-12-31

Last updated

2008-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury, barbiturate coma

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.

Interventions

DRUGPentobarbital

10 mg/kg in 30 minutes; then 5 mg/kg/h during 3 hours; then 1 mg/kg/h

DRUGthiopental

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

15 Years to 75 Years

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

* Previously known ischemic heart failure (Ejection fraction \< 35%) * Pregnancy * bilateral dilated and unreactive pupils and a GCS of 3 * Intolerance to barbiturates

Design outcomes

Primary

Measure	Time frame
Intracranial pressure control	along intensive care unit stay

Secondary

Measure	Time frame
Hypotension (Mean arterial blood pressure<80 mmHg)	during barbiturate treatment
Infection	during barbiturate treatment

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026