Supratentorial NeoplasmsMANNITOLNCT02168075
Mannitol Brain Relaxation Effect
A study testing 0.25g/kgof 20% mannitol, 0.5g/kg of 20% mannitol and 1.0g/kg of 20% mannitol in people with Supratentorial Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Mannitol is widely used in patients with elevated intracranial pressure. In neurosurgical field, especially in large size or with brain edema, it is necessary to decrease brain volume to facilitate surgical approach. In general, 0.25 -1.5g of mannitol per kilogram has been known to decrease ICP effectively. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Supratentorial Neoplasms
- What is being tested?
- 0.25g/kgof 20% mannitol, 0.5g/kg of 20% mannitol and 1.0g/kg of 20% mannitol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to May 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent craniotomy for supratentorial brain tumor under general anesthesia
Who cannot join
- Patient who does not agree to the study
- Patients with or American Society of Anesthesiologists (ASA) physical status class IV or more
- Patients with glasgow coma scale (GCS) under 13 points
- Patients who have hyponatremia or hypernatremia (Na<130 or >150mEq/L)
- Patients who have congestive heart failure or moderately decreased renal function (GFR <60ml/min/1.73m2)
- Patients with extraventricular drainage such as external ventricular drain (EVD) or ventriculoperitoneal (VP) shunt
- Patients who already under mannitolization
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University of Hospital
Seoul, 110-799
Hee Pyung Park, MD PhD, 82-2-2072-2466, hppark@snu.ac.kr
Eugene Kim, MD, 82-2-2072-3108, tomomie@hanmail.net
About this study
Official title: Can Mannitol Increments Provide More Brain Relaxation in Patients Undergoing Craniotomy for Supratentorial Brain Tumor Removal?
Mannitol is widely used in patients with elevated intracranial pressure. In neurosurgical field, especially in large size or with brain edema, it is necessary to decrease brain volume to facilitate surgical approach. In general, 0.25 -1.5g of mannitol per kilogram has been known to decrease ICP effectively. But there are some debates in regard to appropriate dose of mannitol.
Read the detailed description
Previous meta-analysis reported that mannitol has dose-response relationship with intracranial pressure. Another study of Sorani showed dose-response relationship between mannitol and intracranial pressure (ICP) in traumatic brain injury patients.
In this study, authors would investigate that mannitol increments can provide more brain relaxation in patients undergoing craniotomy for supratentorial brain tumor removal.
- Conditions
- Supratentorial Neoplasms
- Being tested
- 0.25g/kgof 20% mannitol, 0.5g/kg of 20% mannitol, 1.0g/kg of 20% mannitol, 1.5g/kg of 20% mannitol
- Medical subject headings
- Supratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25g/kgof 20% mannitolDrug
When the neurosurgeon starts the drilling of skull, 0.25g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).
0.5g/kg of 20% mannitolDrug
When the neurosurgeon starts the drilling of skull, 0.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).
1.0g/kg of 20% mannitolDrug
When the neurosurgeon starts the drilling of skull, 1.0g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).
1.5g/kg of 20% mannitolDrug
When the neurosurgeon starts the drilling of skull,1.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 0.25g/kgof 20% mannitol administered at drilling of skull. Receives: Drug: 0.25g/kgof 20% mannitol |
| Group 2 | Experimental | 0.5g/kg of 20% mannitol administered at drilling of skull. Receives: Drug: 0.5g/kg of 20% mannitol |
| Group 3 | Experimental | 1.0 g/kg of 20% mannitol administered at drilling of skull. Receives: Drug: 1.0g/kg of 20% mannitol |
| Group 4 | Experimental | 1.5g/kg of 20% mannitol administered at drilling of skull. Receives: Drug: 1.5g/kg of 20% mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain parenchymal relaxation
Brain relaxation was assessed immediately after opening of the dura on a scale range from 1 to 4 (1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed) by neurosurgeon who is blinded to dose of mannitol.
3 and 4 scale means brain relaxed. We would analyse if the success proportion of brain relaxation increase according to the mannitol increment 0.25g/kg, 0.5g/kg, 1.0g/kg and 1.5g/kg using Cochran-Armitage trend test.
Measured: intraoperative
Secondary outcomes (5)
Hemodynamic change
Check the mean arterial blood pressure (ABP), heart rate (HR), central venous pressure (CVP) at baseline, 30min, 60min, and 180 min after skin incision. Baseline value means data of just after anesthetic induction.
Measured: at baseline, 30 min, 60min and 180 min after the administration of the study drug
Electrolyte change
Check the serum laboratory result of electrolyte include potassium, sodium immediately before the infusion of mannitol and 30, 60 and 180 min after the administration of the study drug.
Measured: at baseline, 30 min, 60min and 180 min after the administration of the study drug
Brain relaxation score
Brain relaxation was assessed immediately after opening of the dura on a scale range from 1 to 4 (1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed) by neurosurgeon who is blinded to dose of mannitol.
Measured: intraoperative
Urine output
check the urine amount at baseline (just after induction of anesthesia), 30min/60min/180min after mannitol loading.
Measured: at just after induction of anesthesia, 30min, 60min and 180 min after mannitl loading
Osmolar gap change
Check the serum osmolarity, blood urea nitrogen (BUN), glucose immediately before the infusion of mannitol and 30, 60, and 180 minutes after the administration of the study drug for calculate the osmolar gap.
Osmolar gap (OG) = measured osmolarity - calculated osmolarity Calculated osmolarity = 2x[Na(mMol)]+1.15x([glucose(mg/dL)/18)+([urea(mg/dL)/2.8)
Measured: at baseline, 30min, 60min and 180 min after the administration of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supratentorial NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
- Investigators
- Hee Pyung Park, MD PhD, Study director, ProfessorEugene Kim, MD, Principal investigator, Clinical Instuctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168075
- Sponsor's protocol ID
- Mannitol
- Acronym
- MANNITOL
- Status last verified
- Oct 2014
- First submitted
- 16 Jun 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Seo H, Kim E, Jung H, Lim YJ, Kim JW, Park CK, Se YB, Jeon YT, Hwang JW, Park HP. A prospective randomized trial of the optimal dose of mannitol for intraoperative brain relaxation in patients undergoing craniotomy for supratentorial brain tumor resection. J Neurosurg. 2017 Jun;126(6):1839-1846. doi: 10.3171/2016.6.JNS16537. Epub 2016 Aug 19.
PubMed 27540904
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Mannitol Increments Provide More Brain Relaxation in Patients Undergoing Craniotomy for Supratentorial Brain Tumor Removal?
- ClinicalTrials.gov ID
- NCT02168075
- Acronym / sponsor ID
- MANNITOL / Mannitol
- Conditions
- Supratentorial Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2016 (estimated)
- First posted
- 20 Jun 2014 (estimated)
- 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.
Mannitol is widely used in patients with elevated intracranial pressure. In neurosurgical field, especially in large size or with brain edema, it is necessary to decrease brain volume to facilitate surgical approach. In general, 0.25 -1.5g of mannitol per kilogram has been known to decrease ICP effectively. But there are some debates in regard to appropriate dose of mannitol.
Detailed description
Previous meta-analysis reported that mannitol has dose-response relationship with intracranial pressure. Another study of Sorani showed dose-response relationship between mannitol and intracranial pressure (ICP) in traumatic brain injury patients.
In this study, authors would investigate that mannitol increments can provide more brain relaxation in patients undergoing craniotomy for supratentorial brain tumor removal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: 0.25g/kgof 20% mannitol0.25g/kgof 20% mannitol administered at drilling of skull. |
| Group 2 | Experimental | Drug: 0.5g/kg of 20% mannitol0.5g/kg of 20% mannitol administered at drilling of skull. |
| Group 3 | Experimental | Drug: 1.0g/kg of 20% mannitol1.0 g/kg of 20% mannitol administered at drilling of skull. |
| Group 4 | Experimental | Drug: 1.5g/kg of 20% mannitol1.5g/kg of 20% mannitol administered at drilling of skull. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent craniotomy for supratentorial brain tumor under general anesthesia
Key exclusion criteria (7 listed)
- Patient who does not agree to the study
- Patients with or American Society of Anesthesiologists (ASA) physical status class IV or more
- Patients with glasgow coma scale (GCS) under 13 points
- Patients who have hyponatremia or hypernatremia (Na<130 or >150mEq/L)
- Patients who have congestive heart failure or moderately decreased renal function (GFR <60ml/min/1.73m2)
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 |
|---|---|---|
| 0.25g/kgof 20% mannitolWhen the neurosurgeon starts the drilling of skull, 0.25g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed). | Drug | Group 1 |
| 0.5g/kg of 20% mannitolWhen the neurosurgeon starts the drilling of skull, 0.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed). | Drug | Group 2 |
| 1.0g/kg of 20% mannitolWhen the neurosurgeon starts the drilling of skull, 1.0g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed). | Drug | Group 3 |
| 1.5g/kg of 20% mannitolWhen the neurosurgeon starts the drilling of skull,1.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed). | Drug | Group 4 |
Primary outcome
brain parenchymal relaxation
Time frame: intraoperative
Brain relaxation was assessed immediately after opening of the dura on a scale range from 1 to 4 (1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed) by neurosurgeon who is blinded to dose of mannitol. 3 and 4 scale means brain relaxed. We would analyse if the success proportion of brain relaxation increase according to the mannitol increment 0.25g/kg, 0.5g/kg, 1.0g/kg and 1.5g/kg using Cochran-Armitage trend test.
5 secondary outcomes
Hemodynamic change
Time frame: at baseline, 30 min, 60min and 180 min after the administration of the study drug
Electrolyte change
Time frame: at baseline, 30 min, 60min and 180 min after the administration of the study drug
Brain relaxation score
Time frame: intraoperative
Urine output
Time frame: at just after induction of anesthesia, 30min, 60min and 180 min after mannitl loading
Osmolar gap change
Time frame: at baseline, 30min, 60min and 180 min after the administration of the study drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
- Derived from this study: PubMed 27540904Seo H, Kim E, Jung H, Lim YJ, Kim JW, Park CK, Se YB, Jeon YT, Hwang JW, Park HP. A prospective randomized trial of the optimal dose of mannitol for intraoperative brain relaxation in patients undergoing craniotomy for supratentorial brain tumor resection. J Neurosurg. 2017 Jun;126(6):1839-1846. doi: 10.3171/2016.6.JNS16537. Epub 2016 Aug 19.
Related trials for Supratentorial Neoplasms
Recruiting
Perioperative Multimodal Analgesia for Supratentorial Craniotomy
Postoperative Pain, Analgesia
Recruiting
Ketamine Versus Dexmedetomidine as an Adjuvant in Scalp Block in Supratentorial Brain Tumor Excision Surgeries
Regional Anesthesia Morbidity, Supratentorial Brain Tumor
Not yet recruiting
Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy
Postoperative Pain, Analgesia
RecruitingObservational study
FASt Track in Elective Neurosurgery: the Role of Low Propofol Bis-NOL Guided General Anaesthesia for Full, Early and Safe Awakening
Supratentorial Brain Tumor Surgery
Recruiting
Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection
Supratentorial Tumors
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.
Hee Pyung Park, MD PhD study director
Professor
Eugene Kim, MD principal investigator
Clinical Instuctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.25g/kgof 20% mannitol, 0.5g/kg of 20% mannitol and 1.0g/kg of 20% mannitol in people with Supratentorial Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 7 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 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hee Pyung Park, MD PhD (82-2-2072-2466, hppark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain parenchymal relaxation (time frame: intraoperative). 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 NCT02168075, which also lists 1 linked publication.
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 24 Oct 2014; AzTrials last refreshed its copy on 28 Oct 2026.