Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000655448
Ethics application status
Approved
Date submitted
5/04/2016
Date registered
19/05/2016
Date last updated
21/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Comparison of Equivolume, Equimolar Solutions of 3% Hypertonic Saline and
20 % Mannitol for intracranial pressure change in patients undergoing elective supratentorial tumor surgery: A Randomized, Blind Clinical Trial.
Scientific title
A Comparison of Equivolume, Equimolar Solutions of 3% Hypertonic Saline with dose of 5ml/kg and 20 % Mannitol with dose of 1gr/kg for intracranial pressure change in patients undergoing elective supratentorial tumor surgery: A Randomized, Blind Clinical Trial.
Secondary ID [1] 288918 0
none
Universal Trial Number (UTN)
U1111-1181-5107
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
supratentorial tumors 298250 0
high intracranial pressure 298251 0
Condition category
Condition code
Cancer 298395 298395 0 0
Brain
Anaesthesiology 298396 298396 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who were between 18-65 years old and who would have elective supratentorial tumour surgery will be included.After positioning the participant for surgery. Surgeons will open a small hole (diameter is under 5 mm) to cranium. for inserting the intracranial pressure measurement (ICP) probe.Probe will be inserted immediately adjacent the tumor.
Patients will be randomly allocated to an anti-edema treatment arm either Mannitol group (Arm I) and Hypertonic Saline Group (Arm II).
In Arm I: 20 % mannitol (with dose of 1gr/kg) will be given to patients as an intravenous infusion in 15 minutes.
In Arm II: 3% NACL (with dose of 5 ml / kg) will be given to patientsas an intravenous infusion in 15 minutes.
Patients were examined during treatment and 30 minutes after anti-edema treatment. Surgery will not commence until 30 minutes after anti-edema treatment. Patients' intracranial preasure, mean arterial preasure and state entropy values will be measured and recorded before treatment and every 1 minute until examination finished. An arterial blood gas will taken before treatment and every 10 minute until examination finished.( totaly 45 minute).
Intervention code [1] 294381 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297872 0
A Comparison of Equivolume, Equimolar Solutions of 3% Hypertonic Saline with dose of 5ml/kg and 20 % Mannitol with dose of 1gr/kg for intracranial pressure change using an intracranial pressure measurement probe. in patients undergoing elective supratentorial tumor surgery.
Timepoint [1] 297872 0
intracranial preasure values measurred before treatment and every 1 minute from start of mannitol/saline infusion to 30 minutes post end of infusion.
Secondary outcome [1] 322496 0
Mean arterial preasure measurment by invasive arterial pressure monitoring
Timepoint [1] 322496 0
Mean arterial preasure measured before treatment (before mannitol/saline infusion) and every 1 minute from start of mannitol/saline infusion to 30 minutes post end of infusion.

Eligibility
Key inclusion criteria
Patients who between 18-65 years old,who belonged to American society of anesthesiologist classification (ASA) I- III and who would have elective supratentorial tumour surgery will be included.
Other Inclusion criterias are:
1- Patients who didn't have a cranial surgery before.
2- Accepting to attend the research.
3- Patients who are found suitable for intraoperative intracranial pressure monitorization by the surgical team.
4- Patients who were guessed to have a high ICP (having a papilledema or/and having a shift at CT or/and increased ventricle volume).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Patients who have a severe systemic disease( ASA greater than or equal to 4)
2- Patients who have hyponatremia or hypernatremia.
3- Patients who had anti-edematous therapy within 24 hours (mannitol or hypertonic saline)
4- Being allergic to mannitol, hypertonic saline, propofol, rokuronyum, fentanyl,
remifentanyl , midazolam .
5- Patient who are morbid obese ( BMI > 40 )

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/05/2016
Date of last participant enrolment
Anticipated
Actual
31/10/2016
Date of last data collection
Anticipated
Actual
31/10/2016
Sample size
Target
35
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 7767 0
Turkey
State/province [1] 7767 0
istanbul

Funding & Sponsors
Funding source category [1] 293265 0
Self funded/Unfunded
Name [1] 293265 0
achmet ali
Country [1] 293265 0
Turkey
Primary sponsor type
Individual
Name
achmet ali
Address
istanbul medical faculty,Department of Anesthesiology ,turgut ozal cad. no: 12, 34104 istanbul
Country
Turkey
Secondary sponsor category [1] 292068 0
None
Name [1] 292068 0
Address [1] 292068 0
Country [1] 292068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294761 0
Ethics Committee of Istanbul University, Istanbul Medical Faculty
Ethics committee address [1] 294761 0
Ethics committee country [1] 294761 0
Turkey
Date submitted for ethics approval [1] 294761 0
29/04/2015
Approval date [1] 294761 0
08/05/2015
Ethics approval number [1] 294761 0
2015/927

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64906 0
Dr achmet ali
Address 64906 0
istanbul medical faculty, Department of Anesthesiology,turgut ozal cad. no:12 34104 istanbul,turkey
Country 64906 0
Turkey
Phone 64906 0
+905424878264
Fax 64906 0
Email 64906 0
[email protected]
Contact person for public queries
Name 64907 0
achmet ali
Address 64907 0
istanbul medical faculty, Department of Anesthesiology,turgut ozal cad. no:12 34104 istanbul,turkey
Country 64907 0
Turkey
Phone 64907 0
+905424878264
Fax 64907 0
Email 64907 0
[email protected]
Contact person for scientific queries
Name 64908 0
achmet ali
Address 64908 0
istanbul medical faculty, Department of Anesthesiology,turgut ozal cad. no:12 34104 istanbul,turkey
Country 64908 0
Turkey
Phone 64908 0
+905424878264
Fax 64908 0
Email 64908 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComparison of 3% Hypertonic Saline and 20% Mannitol for Reducing Intracranial Pressure in Patients Undergoing Supratentorial Brain Tumor Surgery: A Randomized, Double-blind Clinical Trial.2018https://dx.doi.org/10.1097/ANA.0000000000000446
N.B. These documents automatically identified may not have been verified by the study sponsor.