The Therapeutic Time Window of Mannitol During Craniotomy for Optimal Brain Relaxation in Patients With Supratentorial Tumours

Study Overview
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Brief Summary
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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.

Official Title
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Brain Relaxation Facilitated by Mannitol in Craniotomy: Insight Into the Optimized Operation Window

Conditions
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Supratentorial Tumors

Intervention / Treatment
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* Drug: Mannitol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mannitol A<br>in this group, Mannitol (1.0g/kg) is given just after the induction of general anesthesia | Drug: Mannitol<br>* This drug is in our routine use of neuroanesthesia, are given for facilitate brain relaxation<br>|
| Active Comparator: Mannitol B<br>in this group, Mannitol (1.0g/kg) is given at the time of skin incision | Drug: Mannitol<br>* This drug is in our routine use of neuroanesthesia, are given for facilitate brain relaxation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood sodium levels |  | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain relaxation, mannitol, supratentorial tumours