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

NCT04314674 | Unknown

• 1 other identifier: Neuroanesthesia Cerrahpasa
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brain Tumor - Metastatic; Brain Tumor, Adult: Glioblastoma

Keywords

hypertonic saline, mannitol, supratentorial brain tumor

Outcome Measures

Primary Outcomes (1)

• Brain relaxation score

  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 Outcomes (2)

• Sodium level

  Baseline and after the drug administration 30. min, 2,4,6,8. hours

• Potassium level

  Baseline and after the drug administration 30. min, 2,4,6,8. hours

Study Arms (3)

%3 HS bolus 3 mL.kg-1

ACTIVE COMPARATOR

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

Drug: %3 HS bolus

%3 HS infusion 20 ml/h

ACTIVE COMPARATOR

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

%20 mannitol 0,6 gr.kg-1

ACTIVE COMPARATOR

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

Drug: 20% mannitol

Interventions

%3 HS bolus DRUG

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

Also known as: Group 1

%3 HS bolus 3 mL.kg-1

%3 HS infusion 20 ml/h DRUG

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

Also known as: Group 2

%3 HS infusion 20 ml/h

20% mannitol DRUG

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

Also known as: Group 3

%20 mannitol 0,6 gr.kg-1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective supratentorial tumor resection
• Glioblastoma multiforme
• Metastatic tumor
• Intracranial shift \>0.5 cm
• GCS\>13

You may not qualify if:

• Renal failure
• Heart failure
• Electrolyte imbalance

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (3)

• Quentin C, Charbonneau S, Moumdjian R, Lallo A, Bouthilier A, Fournier-Gosselin MP, Bojanowski M, Ruel M, Sylvestre MP, Girard F. A comparison of two doses of mannitol on brain relaxation during supratentorial brain tumor craniotomy: a randomized trial. Anesth Analg. 2013 Apr;116(4):862-8. doi: 10.1213/ANE.0b013e318282dc70. Epub 2013 Jan 25.

  PMID: 23354336 BACKGROUND

• Dostal P, Dostalova V, Schreiberova J, Tyll T, Habalova J, Cerny V, Rehak S, Cesak T. A comparison of equivolume, equiosmolar solutions of hypertonic saline and mannitol for brain relaxation in patients undergoing elective intracranial tumor surgery: a randomized clinical trial. J Neurosurg Anesthesiol. 2015 Jan;27(1):51-6. doi: 10.1097/ANA.0000000000000091.

  PMID: 25036870 BACKGROUND

• Hernandez-Palazon J, Fuentes-Garcia D, Domenech-Asensi P, Piqueras-Perez C, Falcon-Arana L, Burguillos-Lopez S. A comparison of equivolume, equiosmolar solutions of hypertonic saline and mannitol for brain relaxation during elective supratentorial craniotomy. Br J Neurosurg. 2016;30(1):70-5. doi: 10.3109/02688697.2015.1109061. Epub 2015 Nov 16.

  PMID: 26571037 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Yusuf Tunali

  Professor of the department

  STUDY DIRECTOR

Central Study Contacts

Eren F Akcil

CONTACT

00905327992399; erenfat@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All the patients, the anesthesiologist who will evaluate the postoperative cranial CT will be blind to study group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: March 15, 2020
• First Posted: March 19, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share