Mannitol Brain Relaxation Effect

Not Applicable

• Conditions: Supratentorial Neoplasms
• Interventions: Drug: 0.25g/kgof 20% mannitol; Drug: 1.0g/kg of 20% mannitol; Drug: 0.5g/kg of 20% mannitol; Drug: 1.5g/kg of 20% mannitol

• Registration Number: NCT02168075
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-20
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-24
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	0.25g/kgof 20% mannitol	0.25g/kgof 20% mannitol administered at drilling of skull.
Group 3	1.0g/kg of 20% mannitol	1.0 g/kg of 20% mannitol administered at drilling of skull.
Group 2	0.5g/kg of 20% mannitol	0.5g/kg of 20% mannitol administered at drilling of skull.
Group 4	1.5g/kg of 20% mannitol	1.5g/kg of 20% mannitol administered at drilling of skull.

Primary Outcome Measures

Name	Time	Method
brain parenchymal relaxation	intraoperative	Brain relaxation was assessed immediately after opening of the dura on a scale range from 1 to 4 (1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed) by neurosurgeon who is blinded to dose of mannitol.; 3 and 4 scale means brain relaxed. We would analyse if the success proportion of brain relaxation increase according to the mannitol increment 0.25g/kg, 0.5g/kg, 1.0g/kg and 1.5g/kg using Cochran-Armitage trend test.

Secondary Outcome Measures

Name	Time	Method
Electrolyte change	at baseline, 30 min, 60min and 180 min after the administration of the study drug	Check the serum laboratory result of electrolyte include potassium, sodium immediately before the infusion of mannitol and 30, 60 and 180 min after the administration of the study drug.
Brain relaxation score	intraoperative	Brain relaxation was assessed immediately after opening of the dura on a scale range from 1 to 4 (1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed) by neurosurgeon who is blinded to dose of mannitol.
Hemodynamic change	at baseline, 30 min, 60min and 180 min after the administration of the study drug	Check the mean arterial blood pressure (ABP), heart rate (HR), central venous pressure (CVP) at baseline, 30min, 60min, and 180 min after skin incision. Baseline value means data of just after anesthetic induction.
Urine output	at just after induction of anesthesia, 30min, 60min and 180 min after mannitl loading	check the urine amount at baseline (just after induction of anesthesia), 30min/60min/180min after mannitol loading.
Osmolar gap change	at baseline, 30min, 60min and 180 min after the administration of the study drug	Check the serum osmolarity, blood urea nitrogen (BUN), glucose immediately before the infusion of mannitol and 30, 60, and 180 minutes after the administration of the study drug for calculate the osmolar gap.; Osmolar gap (OG) = measured osmolarity - calculated osmolarity Calculated osmolarity = 2x\[Na(mMol)\]+1.15x(\[glucose(mg/dL)/18)+(\[urea(mg/dL)/2.8)

Trial Locations

Locations (1)

Seoul National University of Hospital; 🇰🇷 Seoul, Korea, Republic of