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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048684
• Other study ID #: FG2010-003
• Status: Completed
• Phase: N/A
• First received: January 13, 2010
• Last updated: May 4, 2011
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Intracranial Pressure

Intervention

Drug:
• Mannitol
Variation of mannitol dose
• Mannitol
Variation of mannitol dose

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Hemodynamic variables: MAP, heart rate		Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol	Yes
Secondary	Temperature		Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol	Yes
Secondary	Urine output		Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol	Yes
Secondary	Perioperative fluid balance and blood loss		Immediately prior to the infusion of mannitol and at 30, 60, 180 minutes after the administration of mannitol	Yes
Secondary	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	Yes