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NCT Number: NCT01048684

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

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.

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Key information

Conditions

Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Intracranial Pressure Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Montreal, Quebec, H2L 4M1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol

Drug

Variation of mannitol dose

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)

    Time frame: At the opening of the dura mater

Secondary outcomes

  1. 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

  2. Temperature

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

  3. Urine output

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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 14, 2010
Registry last updated
May 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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