Brain Tumor - MetastaticNCT04314674
Comparison of Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumors Resection
A study testing %3 HS bolus, %3 HS infusion 20 ml/h and 20% mannitol in people with Brain Tumor - Metastatic and Brain Tumor, Adult: Glioblastoma, run by Istanbul University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Tumor - Metastatic, Brain Tumor, Adult: Glioblastoma
- What is being tested?
- %3 HS bolus, %3 HS infusion 20 ml/h and 20% mannitol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective supratentorial tumor resection
- Glioblastoma multiforme
- Metastatic tumor
- Intracranial shift >0.5 cm
- GCS>13
Who cannot join
- Renal failure
- Heart failure
- Electrolyte imbalance
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Being tested
- %3 HS bolus, %3 HS infusion 20 ml/h, 20% mannitol
- Keywords
- hypertonic saline, mannitol, supratentorial brain tumor
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
%3 HS bolusDrug
Also called Group 1
After head fixation %3 HS bolus 3 ml/kg will be administered
%3 HS infusion 20 ml/hDrug
Also called Group 2
After head fixation %3 HS 20 ml/h infusion will be administered
20% mannitolDrug
Also called Group 3
After head fixation %20 mannitol 0.6 ml/kg will be administered
| Study group | Role | What they receive |
|---|---|---|
| %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. Receives: 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 Receives: 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. Receives: Drug: 20% mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1. min before dura closure
Secondary outcomes (2)
Sodium level
Blood sodium levels obtained from arterial blood gases analysis
Measured: Baseline and after the drug administration 30. min, 2,4,6,8. hours
Potassium level
Blood potassium levels obtained from arterial blood gases analysis
Measured: Baseline and after the drug administration 30. min, 2,4,6,8. hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brain Tumor - MetastaticStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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-1
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eren Fatma Akcil, Istanbul University
- Investigators
- Yusuf Tunali, Study director, Professor of the department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314674
- Sponsor's protocol ID
- Neuroanesthesia Cerrahpasa
- Status last verified
- Mar 2020
- First submitted
- 15 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23354336Dostal 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.
PubMed 25036870Hernandez-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.
PubMed 26571037Akcil EF, Dilmen OK, Tunali Y. Hypertonic saline versus mannitol for brain relaxation in supratentorial tumor surgery: a prospective randomized trial. Braz J Anesthesiol. 2025 Nov-Dec;75(6):844684. doi: 10.1016/j.bjane.2025.844684. Epub 2025 Sep 16.
PubMed 40967382
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04314674
- Acronym / sponsor ID
- Neuroanesthesia Cerrahpasa
- Keywords
- hypertonic saline, mannitol, supratentorial brain tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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-1
| Arm | Type | Receives |
|---|---|---|
| %3 HS bolus 3 mL.kg-1 | Active comparator | Drug: %3 HS bolusAfter the head fixation 3 mL.kg-1 %3 hypertonic saline will be administered over the 20 min intravenously. |
| %3 HS infusion 20 ml/h | Active comparator | Drug: %3 HS infusion 20 ml/hAfter the head fixation 3% hypertonic saline at 20 ml/h infusion rate will be administered during the operation |
| %20 mannitol 0,6 gr.kg-1 | Active comparator | Drug: 20% mannitolAfter the head fixation %20 mannitol 0,6 gr.kg-1 will be administered over the 20 min intravenously. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elective supratentorial tumor resection
- Glioblastoma multiforme
- Metastatic tumor
- Intracranial shift >0.5 cm
- GCS>13
Key exclusion criteria (3 listed)
- Renal failure
- Heart failure
- Electrolyte imbalance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| %3 HS bolusAlso: Group 1After head fixation %3 HS bolus 3 ml/kg will be administered | Drug | %3 HS bolus 3 mL.kg-1 |
| %3 HS infusion 20 ml/hAlso: Group 2After head fixation %3 HS 20 ml/h infusion will be administered | Drug | %3 HS infusion 20 ml/h |
| 20% mannitolAlso: Group 3After head fixation %20 mannitol 0.6 ml/kg will be administered | Drug | %20 mannitol 0,6 gr.kg-1 |
Primary outcome
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
2 secondary outcomes
Sodium level
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Background: PubMed 23354336Quentin 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.
- Background: PubMed 25036870Dostal 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.
- Background: PubMed 26571037Hernandez-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.
- Derived from this study: PubMed 40967382Akcil EF, Dilmen OK, Tunali Y. Hypertonic saline versus mannitol for brain relaxation in supratentorial tumor surgery: a prospective randomized trial. Braz J Anesthesiol. 2025 Nov-Dec;75(6):844684. doi: 10.1016/j.bjane.2025.844684. Epub 2025 Sep 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusuf Tunali study director
Professor of the department
Questions about this trial
What is this clinical trial studying?
A study testing %3 HS bolus, %3 HS infusion 20 ml/h and 20% mannitol in people with Brain Tumor - Metastatic and Brain Tumor, Adult: Glioblastoma, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eren F Akcil (00905327992399, erenfat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain relaxation score (time frame: 1. min before dura closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04314674, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.