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Mannitol Brain Relaxation Effect

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Supratentorial Neoplasms

Intervention: 0.25g/kgof 20% mannitol (Drug); 0.5g/kg of 20% mannitol (Drug); 1.0g/kg of 20% mannitol (Drug); 1.5g/kg of 20% mannitol (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Hee Pyung Park, MD PhD, Study Director, Affiliation: Professor
Eugene Kim, MD, Principal Investigator, Affiliation: Clinical Instuctor

Overall contact:
Hee Pyung Park, MD PhD, Phone: 82-2-2072-2466, Email: hppark@snu.ac.kr

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.

Clinical Details

Official title: Can Mannitol Increments Provide More Brain Relaxation in Patients Undergoing Craniotomy for Supratentorial Brain Tumor Removal?

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: brain parenchymal relaxation

Secondary outcome:

Hemodynamic change

Electrolyte change

Brain relaxation score

Urine output

Osmolar gap change

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.

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Hee Pyung Park, MD PhD, Phone: 82-2-2072-2466, Email: hppark@snu.ac.kr

Seoul National University of Hospital, Seoul 110-799, Korea, Republic of; Recruiting
Hee Pyung Park, MD PhD, Phone: 82-2-2072-2466, Email: hppark@snu.ac.kr
Eugene Kim, MD, Phone: 82-2-2072-3108, Email: tomomie@hanmail.net
Eugene Kim, MD, Principal Investigator
Additional Information

Starting date: June 2014
Last updated: October 23, 2014

Page last updated: August 23, 2015

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