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
Istanbul University, Istanbul Medical Faculty, dekanlik binasi turgut ozal cad. no:12 34104 Istanbul, Turkey
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
The present study aimed to compare that anti-edema effects of hypertonic saline and mannitol.
Patients who are between 18-65 years old,who belonge to ASA I- III and who would have elective supratentorial tumour surgery will be included.
Demographic features of the patients, medications, localization of the tumor, maximum diameter of the tumor measured by CT, volume of the tumor and level of midline shift will be recorded. Initial systolic arterial pressure, mean arterial pressure and diastolic arterial pressure will recorde. Patients will monitored for heart rate (HR) using five-channel ECG, noninvasive blood pressure, peripheral oxygen saturation (SpO2), end-tidal CO2 (ETCO2), state entropy (SE) using an entropy module, and train-of-four (TOF) using a neuromuscular transmission module. For anesthesia induction 1 mcg/kg fentanyl, 0.6mg/kg rocuronium bromure will administered and 1% propofol will be used until the SE value will be below 60. After surgery position, 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 seperated into two groups according to anti-edema treatment randomly as 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 in 15 minutes.
In Arm II: 3% NACL (with ose of 5 ml / kg) will be given to patients in 15 minutes.
Patients were examined during treatment and 30 minutes after anti-edema treatment and surgery not will begin unless examination finished. Patients' intracranial preasure, mean arterial preasure and state entropy values will be measured and recorded before treatment and every 1 minute until examination finished ( totaly 45 minute).
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
Dr 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
Dr 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.