Comparison of Two Doses of Mannitol on Brain Relaxation During Supratentorial Craniotomy
Information source: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Tumor; Intracranial Pressure
Intervention: Mannitol (Drug); Mannitol (Drug)
Phase: N/A
Status: Completed
Sponsored by: Centre hospitalier de l'Université de Montréal (CHUM) Official(s) and/or principal investigator(s): François Girard, MD, FRCPC, Principal Investigator, Affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
Summary
Neuroanesthesia for supratentorial surgery involves a thorough understanding of the
physiopathology of intracranial pressure, cerebral homeostasis and regulation of cerebral
perfusion pressure as well as the effects of anesthesia and surgery on these elements.
The main objective of anesthesia during neurosurgery is to preserve the integrity of the
brain by maintaining cerebral homeostasis, and assuring cerebral protection using
normovolemia, normotension, normoglycemia, moderate hyperoxia and hypocapnia and
hyperosmolality with the administration of mannitol.
During surgery, the use of surgical retractors must be limited to avoid possible ischemia of
the brain tissue. Surgical retractors can be replaced by chemical retractors. The concept
of chemical retraction involves a reduction of cerebral blood flow, maintaining cerebral
perfusion pressure, moderate hyperventilation, drainage of cerebrospinal fluid and
osmotherapy.
Mannitol, an osmotic agent, has been widely used to reduce the volume of the brain, the
intracranial pressure and to facilitate the surgical approach in reducing the risk of
cortical lesions during the opening of the skull.
Mannitol 20% is usually given intravenously in bolus doses of 0. 5-1g/kg over 30 minutes.
However, over the last few years, the concept of a dose-response relationship has emerged.
Some recent studies tend to demonstrate that higher doses of mannitol could reduce
intracranial pressure significantly without any important side effects.
The main objective of the present study is to compare two doses of mannitol (0. 7 and 1. 4
g/kg) on brain relaxation during supratentorial craniotomies.
Clinical Details
Official title: Comparison of Two Doses of Mannitol on Brain Relaxation During Supratentorial Craniotomy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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)
Secondary outcome: Hemodynamic variables: MAP, heart rateTemperature Urine output Perioperative fluid balance and blood loss Laboratory data: blood gases, electrolytes, osmolality, hematocrit, glycemia, lactates
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame, Montreal, Quebec H2L 4M1, Canada
Additional Information
Starting date: April 2010
Last updated: May 4, 2011
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