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

Supratentorial Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444519
• Other study ID #: KY2017-306
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: November 2020
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 1, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Supratentorial Neoplasms
• Supratentorial Tumors

Intervention

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

Locations

Country	Name	City	State
China	Fudan University affiliated Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	just before dural opening
Secondary	Blood sodium levels		change in 30 minute intervals in the first 2 hour after study drug administration
Secondary	Blood potassium levels		change in 30 minute intervals in the first 2 hour after study drug administration
Secondary	Blood chlorine levels		change in 30 minute intervals in the first 2 hour after study drug administration
Secondary	Blood lactate levels		change in 30 minute intervals in the first 2 hour after study drug administration
Secondary	Fluid balance during operation		change in 30 minute intervals in the first 2 hour after study drug administration