Mannitol Brain Relaxation Effect - Clinical Trial for Supratentorial Neoplasms | NCT02168075

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Primary Purpose

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

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

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

NCT ID

NCT02168075

First Posted

June 16, 2014

Last Updated

October 23, 2014

Sponsor

Seoul National University Hospital

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

Mannitol Brain Relaxation Effect (MANNITOL)

Supratentorial Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial