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

NCT01048684 | Completed

• 1 other identifier: FG2010-003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Intracranial Pressure

Keywords

Brain tumor; Intracranial pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Hemodynamic variables: MAP, heart rate

  Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol

• Temperature

  Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol

• Urine output

  Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol

• Perioperative fluid balance and blood loss

  Immediately 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, lactates

  Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: Mannitol

20% Mannitol 1.4 g/kg (high dose)

EXPERIMENTAL

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

Drug: Mannitol

Interventions

Mannitol DRUG

Variation of mannitol dose

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 or older
• Patients who are to undergo an elective supratentorial craniotomy
• Physical status ASA I to IV inclusive.

You may not qualify if:

• Pregnancy
• Severe congestive heart failure
• Severe chronic renal failure
• Recent use (less than 24 hours before surgery)of mannitol or other hypertonic solution

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

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

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• François Girard, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 5, 2011

Record last verified: 2011-05

Locations

CA (1)