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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04314674
Recruitment Status : Not yet recruiting
First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Eren Fatma Akcil, Istanbul University

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.

Condition or disease Intervention/treatment Phase
Brain Tumor - Metastatic Brain Tumor, Adult: Glioblastoma Drug: %3 HS bolus Drug: %3 HS infusion 20 ml/h Drug: 20% mannitol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
Masking Description: All the patients, the anesthesiologist who will evaluate the postoperative cranial CT will be blind to study group
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Active Comparator: %3 HS bolus 3 mL.kg-1
After the head fixation 3 mL.kg-1 %3 hypertonic saline will be administered over the 20 min intravenously.
Drug: %3 HS bolus
After head fixation %3 HS bolus 3 ml/kg will be administered
Other Name: Group 1

Active Comparator: %3 HS infusion 20 ml/h
After the head fixation 3% hypertonic saline at 20 ml/h infusion rate will be administered during the operation
Drug: %3 HS infusion 20 ml/h
After head fixation %3 HS 20 ml/h infusion will be administered
Other Name: Group 2

Active Comparator: %20 mannitol 0,6 gr.kg-1
After the head fixation %20 mannitol 0,6 gr.kg-1 will be administered over the 20 min intravenously.
Drug: 20% mannitol
After head fixation %20 mannitol 0.6 ml/kg will be administered
Other Name: Group 3




Primary Outcome Measures :
  1. Brain relaxation score [ Time Frame: 1. min before dura closure ]
    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 :
  1. Sodium level [ Time Frame: Baseline and after the drug administration 30. min, 2,4,6,8. hours ]
    Blood sodium levels obtained from arterial blood gases analysis

  2. Potassium level [ Time Frame: Baseline and after the drug administration 30. min, 2,4,6,8. hours ]
    Blood potassium levels obtained from arterial blood gases analysis



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314674


Contacts
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Contact: Eren F Akcil 00905327992399 erenfat@yahoo.com

Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Yusuf Tunali Professor of the department
Publications:
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Responsible Party: Eren Fatma Akcil, Associate Professor, Istanbul University
ClinicalTrials.gov Identifier: NCT04314674    
Other Study ID Numbers: Neuroanesthesia Cerrahpasa
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eren Fatma Akcil, Istanbul University:
hypertonic saline, mannitol, supratentorial brain tumor
Additional relevant MeSH terms:
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Neoplasms
Glioblastoma
Brain Neoplasms
Supratentorial Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs