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

Primary Purpose

Brain Tumor, Intracranial Pressure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mannitol
Mannitol
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring Brain tumor, Intracranial pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

20% Mannitol 0.7 g/kg (low-dose)

20% Mannitol 1.4 g/kg (high dose)

Arm Description

Study subjects will be randomized to receive an infusion of 20% mannitol 0.7g/kg over 30 minutes after induction of general anesthesia.

Study subjects will be randomized to receive an infusion of 20% mannitol 1.4 g/kg over 30 minutes after induction of general anesthesia.

Outcomes

Primary Outcome Measures

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 Measures

Hemodynamic variables: MAP, heart rate
Temperature
Urine output
Perioperative fluid balance and blood loss
Laboratory data: blood gases, electrolytes, osmolality, hematocrit, glycemia, lactates

Full Information

First Posted
January 13, 2010
Last Updated
May 4, 2011
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT01048684
Brief Title
Comparison of Two Doses of Mannitol on Brain Relaxation During Supratentorial Craniotomy
Official Title
Comparison of Two Doses of Mannitol on Brain Relaxation During Supratentorial Craniotomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Intracranial Pressure
Keywords
Brain tumor, Intracranial pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20% Mannitol 0.7 g/kg (low-dose)
Arm Type
Active Comparator
Arm Description
Study subjects will be randomized to receive an infusion of 20% mannitol 0.7g/kg over 30 minutes after induction of general anesthesia.
Arm Title
20% Mannitol 1.4 g/kg (high dose)
Arm Type
Experimental
Arm Description
Study subjects will be randomized to receive an infusion of 20% mannitol 1.4 g/kg over 30 minutes after induction of general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Mannitol
Intervention Description
Variation of mannitol dose
Intervention Type
Drug
Intervention Name(s)
Mannitol
Intervention Description
Variation of mannitol dose
Primary Outcome Measure Information:
Title
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)
Time Frame
At the opening of the dura mater
Secondary Outcome Measure Information:
Title
Hemodynamic variables: MAP, heart rate
Time Frame
Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Title
Temperature
Time Frame
Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Title
Urine output
Time Frame
Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Title
Perioperative fluid balance and blood loss
Time Frame
Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol
Title
Laboratory data: blood gases, electrolytes, osmolality, hematocrit, glycemia, lactates
Time Frame
Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Girard, MD, FRCPC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

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

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