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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03444519
Enrollment
100
Registered
2018-02-23
Start date
2018-03-01
Completion date
2019-04-01
Last updated
2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supratentorial Tumors

Keywords

brain relaxation, mannitol, supratentorial tumours

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.

Interventions

DRUGMannitol

This drug is in our routine use of neuroanesthesia, are given for facilitate brain relaxation

Sponsors

Huashan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
brain relaxation scorejust before dural openingdifference 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

MeasureTime frame
Blood sodium levelschange in 30 minute intervals in the first 2 hour after study drug administration
Blood potassium levelschange in 30 minute intervals in the first 2 hour after study drug administration
Blood chlorine levelschange in 30 minute intervals in the first 2 hour after study drug administration
Blood lactate levelschange in 30 minute intervals in the first 2 hour after study drug administration
Fluid balance during operationchange in 30 minute intervals in the first 2 hour after study drug administration

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026