Mannitol Brain Relaxation Effect

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Brief Summary

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Mannitol is widely used in patients with elevated intracranial pressure. In neurosurgical field, especially in large size or with brain edema, it is necessary to decrease brain volume to facilitate surgical approach. In general, 0.25 -1.5g of mannitol per kilogram has been known to decrease ICP effectively. But there are some debates in regard to appropriate dose of mannitol.

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Detailed Description

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Previous meta-analysis reported that mannitol has dose-response relationship with intracranial pressure. Another study of Sorani showed dose-response relationship between mannitol and intracranial pressure (ICP) in traumatic brain injury patients.

In this study, authors would investigate that mannitol increments can provide more brain relaxation in patients undergoing craniotomy for supratentorial brain tumor removal.

Conditions

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Supratentorial Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Group 1

0.25g/kgof 20% mannitol administered at drilling of skull.

Group Type EXPERIMENTAL

0.25g/kgof 20% mannitol

Intervention Type DRUG

When the neurosurgeon starts the drilling of skull, 0.25g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).

Group 2

0.5g/kg of 20% mannitol administered at drilling of skull.

Group Type EXPERIMENTAL

0.5g/kg of 20% mannitol

Intervention Type DRUG

When the neurosurgeon starts the drilling of skull, 0.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).

Group 3

1.0 g/kg of 20% mannitol administered at drilling of skull.

Group Type EXPERIMENTAL

1.0g/kg of 20% mannitol

Intervention Type DRUG

When the neurosurgeon starts the drilling of skull, 1.0g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).

Group 4

1.5g/kg of 20% mannitol administered at drilling of skull.

Group Type EXPERIMENTAL

1.5g/kg of 20% mannitol

Intervention Type DRUG

When the neurosurgeon starts the drilling of skull,1.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).

Interventions

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0.25g/kgof 20% mannitol

When the neurosurgeon starts the drilling of skull, 0.25g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).

Intervention Type DRUG

0.5g/kg of 20% mannitol

When the neurosurgeon starts the drilling of skull, 0.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).

Intervention Type DRUG

1.0g/kg of 20% mannitol

When the neurosurgeon starts the drilling of skull, 1.0g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).

Intervention Type DRUG

1.5g/kg of 20% mannitol

When the neurosurgeon starts the drilling of skull,1.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent craniotomy for supratentorial brain tumor under general anesthesia

Exclusion Criteria

* Patient who does not agree to the study
* Patients with or American Society of Anesthesiologists (ASA) physical status class IV or more
* Patients with glasgow coma scale (GCS) under 13 points
* Patients who have hyponatremia or hypernatremia (Na\<130 or \>150mEq/L)
* Patients who have congestive heart failure or moderately decreased renal function (GFR \<60ml/min/1.73m2)
* Patients with extraventricular drainage such as external ventricular drain (EVD) or ventriculoperitoneal (VP) shunt
* Patients who already under mannitolization

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No