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CompletedNCT03444519Updated Nov 20, 2020

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

An interventional study of Mannitol in Supratentorial Tumors, sponsored by Huashan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-11-20.

Sponsored by Huashan Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

02

Conditions studied

  • Supratentorial Tumors

Keywords

  • brain relaxation
  • mannitol
  • supratentorial tumours
03

In context

Supratentorial Neoplasms

22 studies on the registry are indexed under Supratentorial Neoplasms; 3 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 20 interventional studies indexed under Supratentorial Neoplasms.

Browse Supratentorial Neoplasms studies →

Lead sponsor

Huashan Hospital is the lead sponsor of 247 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Decompensated heart failure
  • kidney insufficiency
  • Diabetes insipidus,
  • Electrolyte imbalance and
  • Who are unconscious
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Mannitol A

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

    Drug: Mannitol

  • Active comparator
    Mannitol B

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

    Drug: Mannitol

Interventions

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

06

What researchers measure

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

    Time frame: just before dural opening

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

07

Study locations

1 site
  • Fudan University affiliated Huashan Hospital
    Shanghai, Shanghai 021, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Mar 2019, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2018
First posted
Feb 23, 2018
StartActual
Mar 1, 2018
Primary completionActual
Mar 14, 2019
CompletionActual
Apr 1, 2019
Last update
Nov 20, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03444519
Lead sponsor
Huashan Hospital
Responsible party
le tian wang (Principal Investigator, Huashan Hospital) — Principal investigator
First posted
Feb 23, 2018
Start date
Mar 1, 2018
Primary completion
Mar 14, 2019
Completion
Apr 1, 2019
Last update
Nov 20, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Mannitol

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