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Completed

NCT Number: NCT03444519

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

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.

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Key information

Conditions

Supratentorial Tumors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Supratentorial Neoplasms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University affiliated Huashan Hospital

Shanghai, Shanghai Municipality, 021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Blood sodium levels

    Time frame: change in 30 minute intervals in the first 2 hour after study drug administration

  2. Blood potassium levels

    Time frame: change in 30 minute intervals in the first 2 hour after study drug administration

  3. Blood chlorine levels

    Time frame: change in 30 minute intervals in the first 2 hour after study drug administration

  4. Blood lactate levels

    Time frame: change in 30 minute intervals in the first 2 hour after study drug administration

  5. Fluid balance during operation

    Time frame: change in 30 minute intervals in the first 2 hour after study drug administration

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2018
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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