Protocol summary

Summary
After obtaining written informed consent from eligible patients, and getting an approval from Ethics committee of Ahvaz Jundishapur University of Medical Sciences, a double-blind prospective, randomized study will be done among patients with Brain Tumor Surgery. Thirty four patients scheduled for general anesthesia will be received midazolam one mg intravenously five min before entering the operating room. Premedication will perform with fentanyl two micro gram/kg. General anesthesia will perform with 4 mg/kg sodium thiopental. Inclusion criteria: The parent's consent, Age between 18 and 60 years old, ASA class I. Exclusion criteria: Previous complications with general anesthesia, Heart disease, Metabolic disorders, Chronic alcohol consumption and Brain herniation. Patients will be randomly allocated into two groups according to table of random numbers. Groups "one" and "two" will be received 5 ml/Kg mannitol(20%) Intravenous or 2.5 ml/Kg hypertonic saline(5%) Intravenous at the beginning of the surgery, respectively. The amount of electrolytes (sodium, potassium, chloride) and bicarbonate will be measured before surgery, 120 minutes after the start of surgery and at the end of the surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015060222535N1
Registration date: 2015-06-16, 1394/03/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-06-16, 1394/03/26
Registrant information
Name
Hengameh Rajabzadeh
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1358 9698
Email address
rajabzadeh.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-10-01, 1394/07/09
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of Mannitol 20% and Hypertonic Saline 5% on Electrolyte Balance during Brain Tumor Surgery
Public title
Comparison effects of Mannitol 20% and Hypertonic Saline 5% on Electrolyte Balance during Brain Tumor Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: - The parent's consent - Age between 18 and 60 years old - ASA class I Exclusion criteria: - Previous complications with general anesthesia - Heart disease - Metabolic disorders - Chronic alcohol consumption - Brain herniation
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No. 21, Ave. 1, Golestan Blvd.
City
Ahvaz
Postal code
6135733777
Approval date
2015-05-09, 1394/02/19
Ethics committee reference number
IR.AJUMS.REC.1394.59

Health conditions studied

1

Description of health condition studied
Neoplasm of brain
ICD-10 code
C71.9
ICD-10 code description
Malignant neoplasm of brain(unspecified)

Primary outcomes

1

Description
Serum Sodium
Timepoint
Before surgery, 120 minutes after the start of surgery and at the end of the surgery
Method of measurement
Laboratory

2

Description
Serum Pottasium
Timepoint
before surgery, 120 minutes after the start of surgery and at the end of the surgery
Method of measurement
Laboratory

3

Description
Serum Chlorine
Timepoint
Before surgery, 120 minutes after the start of surgery and at the end of the surgery
Method of measurement
Laboratory

4

Description
Bicarbonate
Timepoint
Before surgery, 120 minutes after the start of surgery and at the end of the surgery
Method of measurement
Laboratory

Secondary outcomes

empty

Intervention groups

1

Description
Mannitol(20%): Dose: 5 ml/kg Number of using: Once Factory name: Razi Manufacturing Country's Name: Iran Location prescribed: Intravenous Injection Administration time: At the beginning of the surgery
Category
Treatment - Drugs

2

Description
Hypertonic Saline(5%): Dose: 2.5 ml/kg Number of using: Once Factory name: Alborz Manufacturing Country's Name: Iran Location prescribed: Intravenous Injection Administration time: At the beginning of the surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Educational Hospital
Full name of responsible person
Dr, Nozar Nasajian
Street address
No. 307, Kokab Street, Masters Alley, Golestan Blvd.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
No. 21, Ave. 1, Golestan Blvd.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hengameh Rajabzadeh
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
No. 12, Enghelab Chamber, Golestan Blvd.
City
Ahvaz
Postal code
6135733777
Phone
+98 61 1432 5879
Fax
+98 61 1432 5879
Email
Rajabzadeh.h@ajums.ac.ir, fatahi.m@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hengameh Rajabzadeh
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
No. 12, Enghelab Chamber, Golestan Blvd.
City
Ahvaz
Postal code
6135733777
Phone
+98 61 1432 5879
Fax
+98 61 1432 5879
Email
Rajabzadeh.h@ajums.ac.ir, fatahi.m@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hengameh Rajabzadeh
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
No. 12, Enghelab Chamber, Golestan Blvd.
City
Ahvaz
Postal code
6135733777
Phone
+98 61 1432 5879
Fax
+98 61 1432 5879
Email
Rajabzadeh.h@ajums.ac.ir, fatahi.m@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...