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

Primary Purpose

Supratentorial Tumors

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Mannitol

About this trial

This is an interventional other trial for Supratentorial Tumors focused on measuring brain relaxation, mannitol, supratentorial tumours

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Fudan University affiliated Huashan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mannitol A

Mannitol B

Arm Description

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

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

Outcomes

Primary Outcome Measures

brain relaxation score

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

Blood potassium levels

Blood chlorine levels

Blood lactate levels

Fluid balance during operation

Full Information

NCT ID

NCT03444519

First Posted

February 1, 2018

Last Updated

November 18, 2020

Sponsor

Huashan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03444519

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

March 14, 2019 (Actual)

Study Completion Date

April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Supratentorial Tumors

Keywords

brain relaxation, mannitol, supratentorial tumours

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mannitol A

Arm Type

Experimental

Arm Description

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

Arm Title

Mannitol B

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Mannitol

Intervention Description

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

Primary Outcome Measure Information:

Title

brain relaxation score

Description

Time Frame

just before dural opening

Secondary Outcome Measure Information:

Title

Blood sodium levels

Time Frame