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 changeElectrolyte 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
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