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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]

none

Universal Trial Number (UTN)

U1111-1181-5107

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

supratentorial tumors

high intracranial pressure

Condition category

Condition code

Cancer

Brain

Anaesthesiology

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]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

Mean arterial preasure measurment by invasive arterial pressure monitoring

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

istanbul

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

achmet ali

Address [1]

istanbul medical faculty,Department of Anesthesiology ,turgut ozal cad. no: 12, 34104 istanbul

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of Istanbul University, Istanbul Medical Faculty

Ethics committee address [1]

Istanbul University, Istanbul Medical Faculty, dekanlik binasi turgut ozal cad. no:12 34104 Istanbul, Turkey

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

29/04/2015

Approval date [1]

08/05/2015

Ethics approval number [1]

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

Dr achmet ali

Address

istanbul medical faculty, Department of Anesthesiology,turgut ozal cad. no:12 34104 istanbul,turkey

Country

Turkey

Phone

+905424878264

Fax

a_achmet@hotmail.com

Contact person for public queries

Name

achmet ali

Address

istanbul medical faculty, Department of Anesthesiology,turgut ozal cad. no:12 34104 istanbul,turkey

Country

Turkey

Phone

+905424878264

Fax

a_achmet@hotmail.com

Contact person for scientific queries

Name

achmet ali

Address

istanbul medical faculty, Department of Anesthesiology,turgut ozal cad. no:12 34104 istanbul,turkey

Country

Turkey

Phone

+905424878264

Fax

a_achmet@hotmail.com

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

Source	Title	Year of Publication	DOI
Embase	Comparison of 3% Hypertonic Saline and 20% Mannitol for Reducing Intracranial Pressure in Patients Undergoing Supratentorial Brain Tumor Surgery: A Randomized, Double-blind Clinical Trial.	2018	https://dx.doi.org/10.1097/ANA.0000000000000446

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically