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

NCT ID: NCT03444519

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-04-01

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.

Detailed Description

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Conditions

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Supratentorial Tumors

Keywords

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brain relaxation mannitol supratentorial tumours

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mannitol A

in this group, Mannitol (1.0g/kg) is given just after the induction of general anesthesia

Group Type EXPERIMENTAL

Mannitol

Intervention Type DRUG

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

Mannitol B

in this group, Mannitol (1.0g/kg) is given at the time of skin incision

Group Type ACTIVE_COMPARATOR

Mannitol

Intervention Type DRUG

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

Interventions

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Mannitol

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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le tian wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University affiliated Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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KY2017-306

Identifier Type: -

Identifier Source: org_study_id