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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04314674
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Istanbul University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Yusuf Tunali
Principal Investigator Affiliation Professor of the department
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain Tumor - Metastatic, Brain Tumor, Adult: Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

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.

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

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.

Interventions

Drug: - %3 HS bolus

After head fixation %3 HS bolus 3 ml/kg will be administered

Drug: - %3 HS infusion 20 ml/h

After head fixation %3 HS 20 ml/h infusion will be administered

Drug: - 20% mannitol

After head fixation %20 mannitol 0.6 ml/kg will be administered

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Eren F Akcil

[email protected]

00905327992399

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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