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

Istanbul University

Status: Unknown

Conditions: Brain Tumor, Adult: Glioblastoma; Brain Tumor - Metastatic

Treatments: Drug: 20% mannitol; Drug: %3 HS infusion 20 ml/h; Drug: %3 HS bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT04314674

Neuroanesthesia Cerrahpasa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

%3 HS bolus 3 mL.kg-1

Active Comparator group

Description:

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

Treatment:

Drug: %3 HS bolus

%3 HS infusion 20 ml/h

Active Comparator group

Description:

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

Treatment:

Drug: %3 HS infusion 20 ml/h

%20 mannitol 0,6 gr.kg-1

Active Comparator group

Description:

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

Treatment:

Drug: 20% mannitol