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Mannitol Brain Relaxation Effect (MANNITOL)

Primary Purpose

Supratentorial Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
0.25g/kgof 20% mannitol
0.5g/kg of 20% mannitol
1.0g/kg of 20% mannitol
1.5g/kg of 20% mannitol
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Supratentorial Neoplasms

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University of HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

0.25g/kgof 20% mannitol administered at drilling of skull.

0.5g/kg of 20% mannitol administered at drilling of skull.

1.0 g/kg of 20% mannitol administered at drilling of skull.

1.5g/kg of 20% mannitol administered at drilling of skull.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Urine output
check the urine amount at baseline (just after induction of anesthesia), 30min/60min/180min after mannitol loading.
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)

Full Information

First Posted
June 16, 2014
Last Updated
October 23, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02168075
Brief Title
Mannitol Brain Relaxation Effect
Acronym
MANNITOL
Official Title
Can Mannitol Increments Provide More Brain Relaxation in Patients Undergoing Craniotomy for Supratentorial Brain Tumor Removal?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supratentorial Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
0.25g/kgof 20% mannitol administered at drilling of skull.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
0.5g/kg of 20% mannitol administered at drilling of skull.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
1.0 g/kg of 20% mannitol administered at drilling of skull.
Arm Title
Group 4
Arm Type
Experimental
Arm Description
1.5g/kg of 20% mannitol administered at drilling of skull.
Intervention Type
Drug
Intervention Name(s)
0.25g/kgof 20% mannitol
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
0.5g/kg of 20% mannitol
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
1.0g/kg of 20% mannitol
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
1.5g/kg of 20% mannitol
Intervention Description
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).
Primary Outcome Measure Information:
Title
brain parenchymal relaxation
Description
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.
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Hemodynamic change
Description
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.
Time Frame
at baseline, 30 min, 60min and 180 min after the administration of the study drug
Title
Electrolyte change
Description
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.
Time Frame
at baseline, 30 min, 60min and 180 min after the administration of the study drug
Title
Brain relaxation score
Description
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.
Time Frame
intraoperative
Title
Urine output
Description
check the urine amount at baseline (just after induction of anesthesia), 30min/60min/180min after mannitol loading.
Time Frame
at just after induction of anesthesia, 30min, 60min and 180 min after mannitl loading
Title
Osmolar gap change
Description
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)
Time Frame
at baseline, 30min, 60min and 180 min after the administration of the study drug
Other Pre-specified Outcome Measures:
Title
Arterial blood gas analysis (ABGA) change
Description
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.
Time Frame
at baseline, 30min, 60min and 180 min after the administration of the study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Pyung Park, MD PhD
Phone
82-2-2072-2466
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Eugene Kim, MD
Phone
82-2-2072-3108
Email
tomomie@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Pyung Park, MD PhD
Organizational Affiliation
Professor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eugene Kim, MD
Organizational Affiliation
Clinical Instuctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University of Hospital
City
Seoul
ZIP/Postal Code
110-799
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Pyung Park, MD PhD
Phone
82-2-2072-2466
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Eugene Kim, MD
Phone
82-2-2072-3108
Email
tomomie@hanmail.net
First Name & Middle Initial & Last Name & Degree
Eugene Kim, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
27540904
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. Erratum In: J Neurosurg. 2018 Aug 1;129(2):551-552.
Results Reference
derived

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Mannitol Brain Relaxation Effect

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