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

NCT03444519 | Completed DMC

• 1 other identifier: KY2017-306
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Supratentorial Tumors

Keywords

brain relaxation; mannitol; supratentorial tumours

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Mannitol A

EXPERIMENTAL

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

Drug: Mannitol

Mannitol B

ACTIVE COMPARATOR

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

Drug: Mannitol

Interventions

Mannitol DRUG

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

Mannitol A; Mannitol B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Intracranial shift \>3mm
• Scheduled for supratentorial mass resection under elective conditions

You may not qualify if:

• Decompensated heart failure
• kidney insufficiency
• Diabetes insipidus,
• Electrolyte imbalance and
• Who are unconscious

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Fudan University affiliated Huashan Hospital

Shanghai, Shanghai Municipality, 021, China

Location

MeSH Terms

Conditions

Supratentorial Neoplasms

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 23, 2018
• Study Start: March 1, 2018
• Primary Completion: March 14, 2019
• Study Completion: April 1, 2019
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

CN (1)