Trial | NCT00622570  Report issue

Title

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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    44
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.
Study Started
May 31
2002
Primary Completion
Jul 31
2007
Study Completion
Dec 31
2007
Last Update
Feb 25
2008
Estimate

Drug Pentobarbital

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

  • Other names: Nembutal(r)

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 names: PENTOTHAL(R)

1 Experimental

Pentobarbital

2 Active Comparator

thiopental

Criteria 

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
No Results Posted