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Comparison of Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumors Resection

Primary Purpose

Brain Tumor - Metastatic, Brain Tumor, Adult: Glioblastoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
%3 HS bolus
%3 HS infusion 20 ml/h
20% mannitol
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumor - Metastatic focused on measuring hypertonic saline, mannitol, supratentorial brain tumor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Elective supratentorial tumor resection
  • Glioblastoma multiforme
  • Metastatic tumor
  • Intracranial shift >0.5 cm
  • GCS>13

Exclusion Criteria:

  • Renal failure
  • Heart failure
  • Electrolyte imbalance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    %3 HS bolus 3 mL.kg-1

    %3 HS infusion 20 ml/h

    %20 mannitol 0,6 gr.kg-1

    Arm Description

    After the head fixation 3 mL.kg-1 %3 hypertonic saline will be administered over the 20 min intravenously.

    After the head fixation 3% hypertonic saline at 20 ml/h infusion rate will be administered during the operation

    After the head fixation %20 mannitol 0,6 gr.kg-1 will be administered over the 20 min intravenously.

    Outcomes

    Primary Outcome Measures

    Brain relaxation score
    Brain relaxation score 1: Brain is under the dura, 2: Brain is in the dura level, 3:Brain is above the dura, 4: There is no pulsation in the brain

    Secondary Outcome Measures

    Sodium level
    Blood sodium levels obtained from arterial blood gases analysis
    Potassium level
    Blood potassium levels obtained from arterial blood gases analysis

    Full Information

    First Posted
    March 15, 2020
    Last Updated
    March 17, 2020
    Sponsor
    Istanbul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04314674
    Brief Title
    Comparison of Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumors Resection
    Official Title
    Comparison of Continuous Infusion of 3% Hypertonic Saline, Bolus of 3% Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumor Resection: A Prospective, Randomized, Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2020 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hyperosmotic agents are used to decrease intracranial pressure. The aim of the study is to compare the effects of continuous 3% hypertonic saline (HS), bolus HS and 20% mannitol on intraoperative brain relaxation in patients with raised intracranial pressure during surgery for supratentorial tumors.
    Detailed Description
    After obtaining approval from the ethics committee and informed consent, a total of 90 patients aged 18-70 years, conscious (GCS>13) and American Society of Anesthesiologists (ASA) class I-III, who had intracranial shift >0.5 cm or glioblastoma multiforme or metastatic tumor and who were scheduled for supratentorial mass resection under elective conditions, will be included in the present prospective, randomized, double-blind and placebo-controlled study. Patients with heart failure, kidney insufficiency, diabetes insipidus, electrolyte imbalance and who are unconscious will be excluded from the study. The patients will randomized into 3 groups: Group 1: %3 HS bolus 3 mL.kg-1 Group 2: %3 HS infusion 20 ml/h Group 3: %20 mannitol 0,6 gr.kg-1 After head fixation, all patients will be administered with HS or mannitol (over 20 minutes). Arterial blood gas (ABG) analysis (Cobas b 221 blood gas analyzer, Roche®, Basel, Switzerland) will be made at 30 minute,2,4,6,8. hours. Blood sodium, potassium, chlorine, base excess, lactate levels and blood osmolarity will be recorded in each time intervals. The brain relaxation scale will be recorded at the time of dura opening.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Tumor - Metastatic, Brain Tumor, Adult: Glioblastoma
    Keywords
    hypertonic saline, mannitol, supratentorial brain tumor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group 1: %3 HS bolus 3 mL.kg-1 Group 2: %3 HS infusion 20 ml/h Group 3: %20 mannitol 0,6 gr.kg-1
    Masking
    ParticipantInvestigator
    Masking Description
    All the patients, the anesthesiologist who will evaluate the postoperative cranial CT will be blind to study group
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    %3 HS bolus 3 mL.kg-1
    Arm Type
    Active Comparator
    Arm Description
    After the head fixation 3 mL.kg-1 %3 hypertonic saline will be administered over the 20 min intravenously.
    Arm Title
    %3 HS infusion 20 ml/h
    Arm Type
    Active Comparator
    Arm Description
    After the head fixation 3% hypertonic saline at 20 ml/h infusion rate will be administered during the operation
    Arm Title
    %20 mannitol 0,6 gr.kg-1
    Arm Type
    Active Comparator
    Arm Description
    After the head fixation %20 mannitol 0,6 gr.kg-1 will be administered over the 20 min intravenously.
    Intervention Type
    Drug
    Intervention Name(s)
    %3 HS bolus
    Other Intervention Name(s)
    Group 1
    Intervention Description
    After head fixation %3 HS bolus 3 ml/kg will be administered
    Intervention Type
    Drug
    Intervention Name(s)
    %3 HS infusion 20 ml/h
    Other Intervention Name(s)
    Group 2
    Intervention Description
    After head fixation %3 HS 20 ml/h infusion will be administered
    Intervention Type
    Drug
    Intervention Name(s)
    20% mannitol
    Other Intervention Name(s)
    Group 3
    Intervention Description
    After head fixation %20 mannitol 0.6 ml/kg will be administered
    Primary Outcome Measure Information:
    Title
    Brain relaxation score
    Description
    Brain relaxation score 1: Brain is under the dura, 2: Brain is in the dura level, 3:Brain is above the dura, 4: There is no pulsation in the brain
    Time Frame
    1. min before dura closure
    Secondary Outcome Measure Information:
    Title
    Sodium level
    Description
    Blood sodium levels obtained from arterial blood gases analysis
    Time Frame
    Baseline and after the drug administration 30. min, 2,4,6,8. hours
    Title
    Potassium level
    Description
    Blood potassium levels obtained from arterial blood gases analysis
    Time Frame
    Baseline and after the drug administration 30. min, 2,4,6,8. hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Elective supratentorial tumor resection Glioblastoma multiforme Metastatic tumor Intracranial shift >0.5 cm GCS>13 Exclusion Criteria: Renal failure Heart failure Electrolyte imbalance
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eren F Akcil
    Phone
    00905327992399
    Email
    erenfat@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yusuf Tunali
    Organizational Affiliation
    Professor of the department
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23354336
    Citation
    Quentin C, Charbonneau S, Moumdjian R, Lallo A, Bouthilier A, Fournier-Gosselin MP, Bojanowski M, Ruel M, Sylvestre MP, Girard F. A comparison of two doses of mannitol on brain relaxation during supratentorial brain tumor craniotomy: a randomized trial. Anesth Analg. 2013 Apr;116(4):862-8. doi: 10.1213/ANE.0b013e318282dc70. Epub 2013 Jan 25.
    Results Reference
    background
    PubMed Identifier
    25036870
    Citation
    Dostal P, Dostalova V, Schreiberova J, Tyll T, Habalova J, Cerny V, Rehak S, Cesak T. A comparison of equivolume, equiosmolar solutions of hypertonic saline and mannitol for brain relaxation in patients undergoing elective intracranial tumor surgery: a randomized clinical trial. J Neurosurg Anesthesiol. 2015 Jan;27(1):51-6. doi: 10.1097/ANA.0000000000000091.
    Results Reference
    background
    PubMed Identifier
    26571037
    Citation
    Hernandez-Palazon J, Fuentes-Garcia D, Domenech-Asensi P, Piqueras-Perez C, Falcon-Arana L, Burguillos-Lopez S. A comparison of equivolume, equiosmolar solutions of hypertonic saline and mannitol for brain relaxation during elective supratentorial craniotomy. Br J Neurosurg. 2016;30(1):70-5. doi: 10.3109/02688697.2015.1109061. Epub 2015 Nov 16.
    Results Reference
    background

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    Comparison of Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumors Resection

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