Mannitol Brain Relaxation Effect

Supratentorial Neoplasms Clinical Trial

— MANNITOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02168075
• Other study ID #: Mannitol
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2014
• Last updated: October 23, 2014
• Start date: June 2014

Study information

• Verified date: October 2014
• Source: Seoul National University Hospital
• Contact: Hee Pyung Park, MD PhD
• Phone: 82-2-2072-2466
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Supratentorial Neoplasms

Intervention

Drug:
• 0.25g/kgof 20% mannitol
When the neurosurgeon starts the drilling of skull, 0.25g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).
• 0.5g/kg of 20% mannitol
When the neurosurgeon starts the drilling of skull, 0.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).
• 1.0g/kg of 20% mannitol
When the neurosurgeon starts the drilling of skull, 1.0g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).
• 1.5g/kg of 20% mannitol
When the neurosurgeon starts the drilling of skull,1.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University of Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Arterial blood gas analysis (ABGA) change	Check the arterial blood gas analysis include (pH, PaCO2, PaO2, lactate and hematocrit) immediately before the infusion of mannitol and 30, 60, and 180 minutes after the administration of the study drug.	at baseline, 30min, 60min and 180 min after the administration of the study drug	No
Primary	brain parenchymal relaxation	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.	intraoperative	No
Secondary	Hemodynamic change	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.	at baseline, 30 min, 60min and 180 min after the administration of the study drug	No
Secondary	Electrolyte change	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.	at baseline, 30 min, 60min and 180 min after the administration of the study drug	No
Secondary	Brain relaxation score	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.	intraoperative	No
Secondary	Urine output	check the urine amount at baseline (just after induction of anesthesia), 30min/60min/180min after mannitol loading.	at just after induction of anesthesia, 30min, 60min and 180 min after mannitl loading	No
Secondary	Osmolar gap change	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)	at baseline, 30min, 60min and 180 min after the administration of the study drug	No