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

March 17, 2020 updated by: Eren Fatma Akcil, Istanbul University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

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.

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1. min before dura closure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and after the drug administration 30. min, 2,4,6,8. hours
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
Baseline and after the drug administration 30. min, 2,4,6,8. hours

Collaborators and Investigators

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

Sponsor

Istanbul University

Investigators

  • Study Director: Yusuf Tunali, Professor of the department

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 (ANTICIPATED)

April 1, 2020

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

March 15, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (ACTUAL)

March 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuroanesthesia Cerrahpasa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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