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

Sponsor

Huashan Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03444519

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Supratentorial Tumors	Drug: Mannitol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Mar 14, 2019

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Mannitol A

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

Drug: Mannitol

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

Active Comparator: Mannitol B

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

Drug: Mannitol

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University affiliated Huashan Hospital	Shanghai	Shanghai	China	021

Sponsors and Collaborators

Huashan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

le tian wang, Principal Investigator, Huashan Hospital

ClinicalTrials.gov Identifier:

NCT03444519

Other Study ID Numbers:

KY2017-306

First Posted:

Feb 23, 2018

Last Update Posted:

Nov 20, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by le tian wang, Principal Investigator, Huashan Hospital

brain relaxation

mannitol

supratentorial tumours

Additional relevant MeSH terms:

Supratentorial Neoplasms

Mannitol

Study Results

No Results Posted as of Nov 20, 2020