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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 0.25g/kgof 20% mannitol administered at drilling of skull. |
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| Group 2 | Experimental | 0.5g/kg of 20% mannitol administered at drilling of skull. |
|
| Group 3 | Experimental | 1.0 g/kg of 20% mannitol administered at drilling of skull. |
|
| Group 4 | Experimental | 1.5g/kg of 20% mannitol administered at drilling of skull. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.25g/kgof 20% mannitol | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline, 30 min, 60min and 180 min after the administration of the study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial blood gas analysis (ABGA) change | Check the arterial blood gas analysis include (pH, PaCO2, PaO2, lactate and hematocrit) immediately before the infusion of mannitol and 30, 60, and 180 minutes after the administration of the study drug. | at baseline, 30min, 60min and 180 min after the administration of the study drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hee Pyung Park, MD PhD | Contact | 82-2-2072-2466 | hppark@snu.ac.kr | |
| Eugene Kim, MD | Contact | 82-2-2072-3108 | tomomie@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Hee Pyung Park, MD PhD | Professor | Study Director |
| Eugene Kim, MD | Clinical Instuctor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University of Hospital | Recruiting | Seoul | 110-799 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27540904 | Derived | 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. |
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| ID | Term |
|---|---|
| D015173 | Supratentorial Neoplasms |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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|
| 0.5g/kg of 20% mannitol | Drug | 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% mannitol | Drug | 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% mannitol | Drug | 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). |
|
| 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. |
| 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. | intraoperative |
| Urine output | check the urine amount at baseline (just after induction of anesthesia), 30min/60min/180min after mannitol loading. | 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)](streamdown:incomplete-link) | at baseline, 30min, 60min and 180 min after the administration of the study drug |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |