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

Sponsor
Istanbul University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04314674
Collaborator
(none)
90
3
32

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: %3 HS bolus
  • Drug: %3 HS infusion 20 ml/h
  • Drug: 20% mannitol
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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-1Group 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
Anticipated Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • Group 3
  • Outcome Measures

    Primary Outcome Measures

    1. Brain relaxation score [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 [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 [Baseline and after the drug administration 30. min, 2,4,6,8. hours]

      Blood potassium levels obtained from arterial blood gases analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    • Study Director: Yusuf Tunali, Professor of the department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Eren Fatma Akcil, Associate Professor, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT04314674
    Other Study ID Numbers:
    • Neuroanesthesia Cerrahpasa
    First Posted:
    Mar 19, 2020
    Last Update Posted:
    Mar 19, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eren Fatma Akcil, Associate Professor, Istanbul University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 19, 2020