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Comparison of Two Doses of Mannitol on Brain Relaxation During Supratentorial Craniotomy


N/A
18 Years
N/A
Not Enrolling
Both
Brain Tumor, Intracranial Pressure

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Trial Information

Comparison of Two Doses of Mannitol on Brain Relaxation During Supratentorial Craniotomy


80 patients will be divided in two equal groups (Group 1: to receive 20% mannitol 0.7 g/kg
or Group 2: 1.4 g/kg).

The anesthetic technique and monitoring will be standardized. The administration of
mannitol will start following the induction of general anesthesia. The infusion will be
given intravenously over 30 minutes.

Brain relaxation will be assessed by a senior surgeon at the opening of the dura mater on a
scale from 1 to 4 (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging
brain)

If needed, in case of significant cerebral edema, a rescue dose of 20% mannitol 0.25 g/kg
will be administered.

Hemodynamic variables (MAP, heart rate), temperature, urine output, perioperative fluid
balance, blood loss and laboratory values (blood gases, electrolytes, osmolality,
hematocrit, glycemia, lactates) will be collected immediately prior to the infusion of
mannitol and at 30, 60, 180 minutes following the administration of mannitol.

The type of cerebral lesion, its location and size (in 3 dimensions) will be noted. The
presence of a median-line shift will also be assessed.


Inclusion Criteria:



- Patients aged 18 or older

- Patients who are to undergo an elective supratentorial craniotomy

- Physical status ASA I to IV inclusive.

Exclusion Criteria:

- Pregnancy

- Severe congestive heart failure

- Severe chronic renal failure

- Recent use (less than 24 hours before surgery)of mannitol or other hypertonic
solution

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Brain relaxation at the opening of the dura mater assessed by a senior surgeon on a scale from 1 to 4 (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain)

Outcome Time Frame:

At the opening of the dura mater

Safety Issue:

Yes

Principal Investigator

François Girard, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre hospitalier de l'Université de Montréal (CHUM)

Authority:

Canada: Ethics Review Committee

Study ID:

FG2010-003

NCT ID:

NCT01048684

Start Date:

April 2010

Completion Date:

May 2011

Related Keywords:

  • Brain Tumor
  • Intracranial Pressure
  • Brain tumor
  • Intracranial pressure
  • Brain Neoplasms

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