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Mannitol Brain Relaxation Effect (MANNITOL)

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ClinicalTrials.gov Identifier: NCT02168075
Recruitment Status : Unknown
Verified October 2014 by Hee-Pyoung Park, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : June 20, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Hee-Pyoung Park, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE June 16, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date October 24, 2014
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 17, 2014)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mannitol Brain Relaxation Effect
Official Title  ICMJE Can Mannitol Increments Provide More Brain Relaxation in Patients Undergoing Craniotomy for Supratentorial Brain Tumor Removal?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Supratentorial Neoplasms
Intervention  ICMJE
  • 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).
  • 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).
  • 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).
  • 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).
Study Arms  ICMJE
  • Experimental: Group 1
    0.25g/kgof 20% mannitol administered at drilling of skull.
    Intervention: Drug: 0.25g/kgof 20% mannitol
  • Experimental: Group 2
    0.5g/kg of 20% mannitol administered at drilling of skull.
    Intervention: Drug: 0.5g/kg of 20% mannitol
  • Experimental: Group 3
    1.0 g/kg of 20% mannitol administered at drilling of skull.
    Intervention: Drug: 1.0g/kg of 20% mannitol
  • Experimental: Group 4
    1.5g/kg of 20% mannitol administered at drilling of skull.
    Intervention: Drug: 1.5g/kg of 20% mannitol
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 17, 2014)
124
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168075
Other Study ID Numbers  ICMJE Mannitol
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hee-Pyoung Park, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hee Pyung Park, MD PhD Professor
Principal Investigator: Eugene Kim, MD Clinical Instuctor
PRS Account Seoul National University Hospital
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP