Determining the effect of three types of fluid therapy with one-fifth to four-fifths, Ringer and one-third to two-thirds on blood glucose levels in children aged 0.5-4 years undergoing surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, Phase 3 on 105 children.
Settings and conduct
In this study, 105 children undergoing surgery were randomly assigned in three groups of 35 and intraoperative fluid therapy was performed in the three groups with serum one-fifth-four-fifth, Ringer and one-third-two-thirds, respectively, and blood glucose levels, hemodynamic and electrolyte parameters of patients were measured and compared before surgery to 24 hours after surgery.
Participants/Inclusion and exclusion criteria
Entry requirements: Age range 6 months to 4 years, candidate for surgery under general anesthesia,
Exit conditions: Diabetes Mellitus type 1
Intervention groups
Intervention group 1: one-fifth four-fifths.
Intervention group 2: one third two thirds.
Control group: Ringer.
Comparative evaluation of blood glucose changes, during surgery in children 6 months to 4 years old under 1/5-4/5, ringer and 1/3-2/3 injectable fluid
Public title
Comparative evaluation of blood glucose changes, during surgery in children 6 months to 4 years old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 6 months to 4 years
Consent of the patient's parents to participate in the study
ASA=1,2
Candidate for surgery under general anesthesia
Exclusion criteria:
Patient with type 1 diabetes
Age
From 6 months old to 4 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
They are randomly distributed in three groups of 35 people using the card folding method. In this method, a number of cards or letters selected by the researcher as the first group and the same number of cards for the next second and third groups are considered; Then, by merging the cards together (flipping the cards), a card is taken out and its allocation is recorded. The cards are then merged again and another card is removed. This process continues until a random sequence is reached according to the sample size (35).
Blinding (investigator's opinion)
Not 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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical science-Hezar Jarib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8739118631
Approval date
2017-05-30, 1396/03/09
Ethics committee reference number
IR.MUI.REC.1396.3.953
Health conditions studied
1
Description of health condition studied
blood glucose
ICD-10 code
R73.09
ICD-10 code description
Other abnormal glucose
Primary outcomes
1
Description
Blood sugar level
Timepoint
Hemodynamic parameters are measured and recorded every 15 minutes during surgery and recovery and blood sugar levels at baseline and every one hour during surgery and 2 hours after surgery.
Method of measurement
Glucometer, ABG
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One-fifth four-fifths, Dextrose serum 10% Ghazi 0.5 liters made in Iran and Shahid Ghazi Pharmaceutical Company, hemodynamic parameters every 15 minutes during operation and recovery and blood sugar level at baseline with blood sample, every hour during operation and end of operation with glucometer and 2 hours After surgery with blood sample, electrolyte is measured before and 2 hours after surgery, blood acidity is measured and recorded at 2 hours postoperatively through ABG and urinary output at the end of surgery and at the end of recovery and 2 hours after surgery.
Category
Diagnosis
2
Description
Intervention group: One third two thirds, Dextrose serum 10% Ghazi 0.5 liters made in Iran and Shahid Ghazi Pharmaceutical Company, hemodynamic parameters every 15 minutes during operation and recovery and blood sugar level at baseline with blood sample, every hour during operation and end of operation with glucometer and 2 hours After surgery with blood sample, electrolyte is measured before and 2 hours after surgery, blood acidity is measured and recorded at 2 hours postoperatively through ABG and urinary output at the end of surgery and at the end of recovery and 2 hours after surgery.
Category
Diagnosis
3
Description
Intervention group: Ringer, Ringer Lactate Serum 10% Ghazi 0.5 liters Made in Iran and Shahid Ghazi Pharmaceutical Company, Hemodynamic parameters every 15 minutes during surgery and recovery and blood sugar level at baseline with blood sample, every hour during surgery and end of operation with glucometer and 2 Postoperative saturation with blood sample, electrolyte before and 2 hours after surgery, blood acidity at 2 hours postoperatively through ABG and urinary output at the end of surgery and at the end of recovery and 2 hours after surgery are recorded.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra and Imam Hossein hospital in Isfahan
Full name of responsible person
Maryam Ashrafi
Street address
Hezar Jarib Ave,
City
Isfahan
Province
Isfehan
Postal code
8739118631
Phone
+98 31 5550 0111
Email
m.ashrufi7122@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Ashrafi
Street address
Hezarjarib Ave,
City
Isfahan
Province
Isfehan
Postal code
8739118631
Phone
+98 31 5550 0111
Email
m.ashrufi7122@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parvin Sajedi
Position
Associated
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Hezarjarib Ave,
City
Isfahan
Province
Isfehan
Postal code
8739118631
Phone
+98 31 5550 0111
Email
sajedi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parvin Sajedi
Position
Associated
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Hezarjarib Ave,
City
Isfahan
Province
Isfehan
Postal code
8739118631
Phone
+98 31 5550 0111
Email
sajedi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Ashrafi
Position
Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Isfahan University of Medical Sciences, Hezar Jarib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8739118631
Phone
+98 31 5550 0111
Fax
Email
m.ashrufi7122@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some of the information can be shared
When the data will become available and for how long
4 months after printing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
No analysis will be allowed
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document