Comparison of Equiosmolar Doses of Mannitol 20% Versus Hypertonic Saline 7.5% Infusion in the Reduction of Brain Bulk During Elective Craniotomies for Supratentorial Brain Tumor Resection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Enrollment
- 162
- Locations
- 2
- Primary Endpoint
- Surgeon's assessment of brain bulk.
Study Overview
Brief Summary
The purpose of this study is to evaluate the effect of Hypertonic Saline 7.5% vs Mannitol 20% on brain bulk (using a 4 point scale), intracranial pressure (subdural catheter)and the changes on serum and urinary Na, K and Osmolarity during elective craniotomy for brain tumor resection.
Detailed Description
Raised intracranial pressure occurs following an expansion of an intracranial mass e.g. hematoma or brain tumor and if left untreated, can lead to brain ischemia, stroke and death.
Strategies for reducing raised intracranial pressure include hyperventilation, use of a hyperosmolar agent and the evacuation of the intracranial mass.
The two hypertonic solutions most commonly used are Mannitol 20% and Hypertonic Saline 7.5%.
During elective neurosurgical removal of a brain tumour, the anesthesiologist needs to reduce intracranial pressure and provide good operating brain conditions to avoid brain ischemia.
Currently, Mannitol 20% is routinely used intra-operatively in these patients to reduce brain bulk and intracranial pressure and to improve brain operating conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA physical status I -
- •Age >18 years.
- •Scheduled for elective craniotomies for supratentorial brain tumour resection.
- •Written informed consent.
Exclusion Criteria
- •Within the past six months, a history of unstable angina pectoris and/or having a myocardial infarction.
- •Electrocardiogram abnormalities indicating severe ischemia.
- •Congestive heart failure.
- •Glasgow coma sore < 9
- •Refusal to participate or refusal to agree to randomization.
- •Known renal failure
- •Known poorly controlled diabetes.
Outcomes
Primary Outcomes
Surgeon's assessment of brain bulk.
ICP reduction
Secondary Outcomes
- Changes in intracranial pressure
- Changes in serum and urine levels of sodium, potassium and osmolarity.