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

November 18, 2020 updated by: le tian wang, Huashan Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 021
        • Fudan University Affiliated Huashan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
brain relaxation score
Time Frame: 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
just before dural opening

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood sodium levels
Time Frame: change in 30 minute intervals in the first 2 hour after study drug administration
change in 30 minute intervals in the first 2 hour after study drug administration
Blood potassium levels
Time Frame: change in 30 minute intervals in the first 2 hour after study drug administration
change in 30 minute intervals in the first 2 hour after study drug administration
Blood chlorine levels
Time Frame: change in 30 minute intervals in the first 2 hour after study drug administration
change in 30 minute intervals in the first 2 hour after study drug administration
Blood lactate levels
Time Frame: change in 30 minute intervals in the first 2 hour after study drug administration
change in 30 minute intervals in the first 2 hour after study drug administration
Fluid balance during operation
Time Frame: change in 30 minute intervals in the first 2 hour after study drug administration
change in 30 minute intervals in the first 2 hour after study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

March 14, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

February 19, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2017-306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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