The Therapeutic Time Window of Mannitol During Craniotomy for Optimal Brain Relaxation in Patients With Supratentorial Tumours
- Registration Number
- NCT03444519
- Lead Sponsor
- Huashan Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Intracranial shift >3mm
- Scheduled for supratentorial mass resection under elective conditions
- Decompensated heart failure
- kidney insufficiency
- Diabetes insipidus,
- Electrolyte imbalance and
- Who are unconscious
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mannitol A Mannitol in this group, Mannitol (1.0g/kg) is given just after the induction of general anesthesia Mannitol B Mannitol in this group, Mannitol (1.0g/kg) is given at the time of skin incision
- Primary Outcome Measures
Name Time Method brain relaxation score just before dural opening 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
- Secondary Outcome Measures
Name Time Method Blood sodium levels change in 30 minute intervals in the first 2 hour after study drug administration Blood lactate levels change in 30 minute intervals in the first 2 hour after study drug administration Fluid balance during operation change in 30 minute intervals in the first 2 hour after study drug administration Blood potassium levels change in 30 minute intervals in the first 2 hour after study drug administration Blood chlorine levels change in 30 minute intervals in the first 2 hour after study drug administration
Trial Locations
- Locations (1)
Fudan University affiliated Huashan Hospital
🇨🇳Shanghai, Shanghai, China