Mannitol Brain Relaxation Effect (MANNITOL)

October 23, 2014 updated by: Hee-Pyoung Park, Seoul National University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hee Pyung Park, MD PhD
  • Phone Number: 82-2-2072-2466
  • Email: hppark@snu.ac.kr

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-799
        • Recruiting
        • Seoul National University of Hospital
        • Contact:
        • Principal Investigator:
          • Eugene Kim, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
0.25g/kgof 20% mannitol administered at drilling of skull.
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).
Experimental: Group 2
0.5g/kg of 20% mannitol administered at drilling of skull.
Drug: 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).
Experimental: Group 3
1.0 g/kg of 20% mannitol administered at drilling of skull.
Drug: 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).
Experimental: Group 4
1.5g/kg of 20% mannitol administered at drilling of skull.
Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
brain parenchymal relaxation
Time Frame: intraoperative

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic change
Time Frame: at baseline, 30 min, 60min and 180 min after the administration of the study drug
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
Electrolyte change
Time Frame: at baseline, 30 min, 60min and 180 min after the administration of the study drug
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
Brain relaxation score
Time Frame: intraoperative
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
Urine output
Time Frame: at just after induction of anesthesia, 30min, 60min and 180 min after mannitl loading
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
Osmolar gap change
Time Frame: at baseline, 30min, 60min and 180 min after the administration of the study drug

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial blood gas analysis (ABGA) change
Time Frame: at baseline, 30min, 60min and 180 min after the administration of the study drug
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Hee Pyung Park, MD PhD, professor
  • Principal Investigator: Eugene Kim, MD, Clinical Instuctor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

June 16, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (Estimate)

June 20, 2014

Study Record Updates

Last Update Posted (Estimate)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mannitol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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