Supratentorial TumorsNCT03444519
The Therapeutic Time Window of Mannitol During Craniotomy for Optimal Brain Relaxation in Patients With Supratentorial Tumours
A study testing Mannitol in people with Supratentorial Tumors, run by Huashan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Supratentorial Tumors
- What is being tested?
- Mannitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Intracranial shift >3mm
- Scheduled for supratentorial mass resection under elective conditions
Who cannot join
- Decompensated heart failure
- kidney insufficiency
- Diabetes insipidus,
- Electrolyte imbalance and
- Who are unconscious
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University affiliated Huashan Hospital
Shanghai, Shanghai Municipality, 021
About this study
Official title: Brain Relaxation Facilitated by Mannitol in Craniotomy: Insight Into the Optimized Operation Window
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
- Being tested
- Mannitol
- Keywords
- brain relaxation, mannitol, supratentorial tumours
- Medical subject headings
- Supratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
This drug is in our routine use of neuroanesthesia, are given for facilitate brain relaxation
| Study group | Role | What they receive |
|---|---|---|
| Mannitol A | Experimental | in this group, Mannitol (1.0g/kg) is given just after the induction of general anesthesia Receives: Drug: Mannitol |
| Mannitol B | Active comparator | in this group, Mannitol (1.0g/kg) is given at the time of skin incision Receives: Drug: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: just before dural opening
Secondary outcomes (5)
Blood sodium levels
Measured: change in 30 minute intervals in the first 2 hour after study drug administration
Blood potassium levels
Measured: change in 30 minute intervals in the first 2 hour after study drug administration
Blood chlorine levels
Measured: change in 30 minute intervals in the first 2 hour after study drug administration
Blood lactate levels
Measured: change in 30 minute intervals in the first 2 hour after study drug administration
Fluid balance during operation
Measured: change in 30 minute intervals in the first 2 hour after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Mar 2018
- Primary completion14 Mar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supratentorial TumorsStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, le tian wang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444519
- Sponsor's protocol ID
- KY2017-306
- Status last verified
- Nov 2020
- First submitted
- 1 Feb 2018
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Relaxation Facilitated by Mannitol in Craniotomy: Insight Into the Optimized Operation Window
- ClinicalTrials.gov ID
- NCT03444519
- Acronym / sponsor ID
- KY2017-306
- Conditions
- Supratentorial Tumors
- Keywords
- brain relaxation, mannitol, supratentorial tumours
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mannitol A | Experimental | Drug: Mannitolin this group, Mannitol (1.0g/kg) is given just after the induction of general anesthesia |
| Mannitol B | Active comparator | Drug: Mannitolin this group, Mannitol (1.0g/kg) is given at the time of skin incision |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Intracranial shift >3mm
- Scheduled for supratentorial mass resection under elective conditions
Key exclusion criteria (5 listed)
- Decompensated heart failure
- kidney insufficiency
- Diabetes insipidus,
- Electrolyte imbalance and
- Who are unconscious
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MannitolThis drug is in our routine use of neuroanesthesia, are given for facilitate brain relaxation | Drug | Mannitol A, Mannitol B |
Primary outcome
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
5 secondary outcomes
Blood sodium levels
Time frame: change in 30 minute intervals in the first 2 hour after study drug administration
Blood potassium levels
Time frame: change in 30 minute intervals in the first 2 hour after study drug administration
Blood chlorine levels
Time frame: change in 30 minute intervals in the first 2 hour after study drug administration
Blood lactate levels
Time frame: change in 30 minute intervals in the first 2 hour after study drug administration
Fluid balance during operation
Time frame: change in 30 minute intervals in the first 2 hour after study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mannitol in people with Supratentorial Tumors, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain relaxation score (time frame: just before dural opening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.