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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01048684
Enrollment
80
Registered
2010-01-14
Start date
2010-04-30
Completion date
2011-05-31
Last updated
2011-05-05

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

Conditions

Brain Tumor, Intracranial Pressure

Keywords

Brain tumor, Intracranial pressure

Brief 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.

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.

Interventions

DRUGMannitol

Variation of mannitol dose

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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)At the opening of the dura mater

Secondary

MeasureTime frame
Hemodynamic variables: MAP, heart rateImmediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
TemperatureImmediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Urine outputImmediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Perioperative fluid balance and blood lossImmediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Laboratory data: blood gases, electrolytes, osmolality, hematocrit, glycemia, lactatesImmediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol

Countries

Canada

Outcome results

None listed

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