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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 60 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03444519
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Huashan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Supratentorial Tumors

Arms & Interventions

Arms

Experimental: Mannitol A

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

Active Comparator: Mannitol B

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

Interventions

Drug: - Mannitol

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

Contact a Trial Team

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International Sites

Shanghai, Shanghai, China

Status

Recruiting

Address

Fudan University affiliated Huashan Hospital

Shanghai, Shanghai, 021

Site Contact

zhang junjie, MD

573197697@qq.com

13611880505

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