Mannitol Brain Relaxation Effect (MANNITOL)

Seoul National University

Status: Unknown

Conditions: Supratentorial Neoplasms

Treatments: Drug: 1.5g/kg of 20% mannitol; Drug: 0.5g/kg of 20% mannitol; Drug: 0.25g/kgof 20% mannitol; Drug: 1.0g/kg of 20% mannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT02168075

Mannitol

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 4 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: 0.25g/kgof 20% mannitol

Group 2

Experimental group

Description:

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

Treatment:

Drug: 0.5g/kg of 20% mannitol

Group 3

Experimental group

Description:

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

Treatment:

Drug: 1.0g/kg of 20% mannitol

Group 4

Experimental group

Description:

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

Treatment:

Drug: 1.5g/kg of 20% mannitol