Clinical trial NCT02168075: Mannitol Brain Relaxation Effect
Official title: Can Mannitol Increments Provide More Brain Relaxation in Patients Undergoing Craniotomy for Supratentorial Brain Tumor Removal?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supratentorial Neoplasms
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: brain parenchymal relaxation
timeFrame: intraoperative
Secondary outcomes:
measure: Hemodynamic change
timeFrame: at baseline, 30 min, 60min and 180 min after the administration of the study drug
measure: Electrolyte change
timeFrame: at baseline, 30 min, 60min and 180 min after the administration of the study drug
measure: Brain relaxation score
timeFrame: intraoperative
measure: Urine output
timeFrame: at just after induction of anesthesia, 30min, 60min and 180 min after mannitl loading
measure: Osmolar gap change
timeFrame: at baseline, 30min, 60min and 180 min after the administration of the study drug
Other outcomes:
measure: Arterial blood gas analysis (ABGA) change
timeFrame: at baseline, 30min, 60min and 180 min after the administration of the study drug
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University of Hospital
Study officials:
affiliation: Professor
name: Hee Pyung Park, MD PhD
role: STUDY_DIRECTOR
affiliation: Clinical Instuctor
name: Eugene Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seo H, Kim E, Jung H, Lim YJ, Kim JW, Park CK, Se YB, Jeon YT, Hwang JW, Park HP. A prospective randomized trial of the optimal dose of mannitol for intraoperative brain relaxation in patients undergoing craniotomy for supratentorial brain tumor resection. J Neurosurg. 2017 Jun;126(6):1839-1846. doi: 10.3171/2016.6.JNS16537. Epub 2016 Aug 19.