Supratentorial Tumors Clinical Trial
Official title:
Brain Relaxation Facilitated by Mannitol in Craniotomy: Insight Into the Optimized Operation Window
| NCT number | NCT03444519 |
| Other study ID # | KY2017-306 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 1, 2018 |
| Est. completion date | April 1, 2019 |
| Verified date | November 2020 |
| Source | Huashan Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Although mannitol is used for brain relaxation during neurosurgery and in the treatment of raised intracranial pressure; there is not a consensus on its safe, effective dose and the duration of its administration. This study aimed to compare the effects of the mannitol in different use times, on the brain relaxation, electrolyte, lactate levels of the blood, peroperative fluid balance and the volume of the urine in supratentorial mass resection surgeries.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | April 1, 2019 |
| Est. primary completion date | March 14, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | Inclusion Criteria: - Intracranial shift >3mm - Scheduled for supratentorial mass resection under elective conditions Exclusion Criteria: - Decompensated heart failure - kidney insufficiency - Diabetes insipidus, - Electrolyte imbalance and - Who are unconscious |
| Country | Name | City | State |
|---|---|---|---|
| China | Fudan University affiliated Huashan Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Huashan Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | brain relaxation score | difference in brain relaxation after drug administration
The assessment was performed using a 4-point scale, 1 denoting bulging or the condition that additional methods for brain relaxation are immediately and always required in order to continue the surgical procedure because of brain swelling; 2, firm or the condition that additional methods for brain relaxation are occasionally required to continue the surgical procedure; 3, adequate; 4, perfectly relaxed. In all patients, the degree of brain relaxation was assessed at the time of dural opening and satisfactory brain relaxation was defined as a brain relaxation score of 3 or 4. All the Secondary Outcome Measures below are observed the safety for intraoperative brain debulking during elective supratentorial craniotomy |
just before dural opening | |
| Secondary | Blood sodium levels | change in 30 minute intervals in the first 2 hour after study drug administration | ||
| Secondary | Blood potassium levels | change in 30 minute intervals in the first 2 hour after study drug administration | ||
| Secondary | Blood chlorine levels | change in 30 minute intervals in the first 2 hour after study drug administration | ||
| Secondary | Blood lactate levels | change in 30 minute intervals in the first 2 hour after study drug administration | ||
| Secondary | Fluid balance during operation | change in 30 minute intervals in the first 2 hour after study drug administration |