1. Home
  2. Approved trials
  3. » فارسی

Comparative study of two fluid therapy methods with either normal saline or DW5% NaCl 0.45% effect on blood glucose and plasma electrolyte levels during and after neonatal surgery

Protocol summary

Study aim
Assessing the effect of using either two methods of serum therapy with normal saline or dextrose half saline on vital signs, blood glucose level, sodium and bicarbonate serum levels and mean acidity and base excess of serum during and after neonatal surgery
Design
Clinical trial with two parallel groups, double blinded, block randomized, 78 cases
Settings and conduct
This study will be performed in Isfahan Imam Hossein hospital. The study is double blinded and the patients and statistical data analyzer are blinded.
Participants/Inclusion and exclusion criteria
Neonates aged 1 to 30 days candidate for surgery under general anesthesia with ASA one or two whose parents' have consented to participate in the study
Intervention groups
Intervention group A consists of neonates who will be receiving normal saline during surgery and intervention group B consists of neonates who will be receiving dextrose half saline during surgery.
Main outcome variables
Vital signs, Blood glucose level, Sodium and bicarbonate serum levels and mean acidity and base excess of serum

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200229046645N1
Registration date: 2020-04-14, 1399/01/26
Registration timing: registered_while_recruiting

Last update: 2020-04-14, 1399/01/26
Update count: 0
Registration date
2020-04-14, 1399/01/26
Registrant information
Name
Negin khavarian moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 2634
Email address
negin.khavarian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2020-06-18, 1399/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of two fluid therapy methods with either normal saline or DW5% NaCl 0.45% effect on blood glucose and plasma electrolyte levels during and after neonatal surgery
Public title
Assessing the effect of fluid therapy with either normal saline or dextrose half saline on blood glucose and plasma electrolyte levels in neonatal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for surgery under general anesthesia ASA=1,2 Parental consent of the patients to participate in the study
Exclusion criteria:
Presence of any underlying disease in the neonate
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 78
More than 1 sample in each individual
Number of samples in each individual: 9
Average heart rate, Average respiratory rate, Average of mean arterial pressure, Average percent of arterial blood O2 saturation, Average Sodium serum level, Average Bicarbonate serum level, Serum glucose level, Average serum pH, Average serum BE
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is performed in a way that all blocks have the same size of six participants. Each block has three participants in the intervention group A and three participants in the intervention group B (Randomization is used to choose participants in each intervention group).
Blinding (investigator's opinion)
Double blinded
Blinding description
Parents of patients and data analyzer are unaware of how the patients are grouped.
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
Milad dormitory, dormitory collection of Isfahan University of Medical science, Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-12-05, 1397/09/14
Ethics committee reference number
IR.MUI.MED.REC.1398.183

Health conditions studied

1

Description of health condition studied
Vital signs during neonatal surgery, Mean serum sodium and bicarbonate during neonatal surgery, Mean acidity and base excess during neonatal surgery, Blood glucose level during neonatal surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Vital signs
Timepoint
Beginning of the surgery, 15th minute of the surgery, 30th minute of the surgery
Method of measurement
Patient monitoring machine

2

Description
Sodium and bicarbonate serum levels
Timepoint
Beginning of the surgery, End of the surgery, 2 hours after the surgery
Method of measurement
Blood sample

3

Description
Serum acidity and base excess
Timepoint
End of the surgery
Method of measurement
Blood sample

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A: Patients who receive 10 cc per kilogram body weight normal saline as serum therapy during the surgery
Category
Treatment - Other

2

Description
Intervention group B: Patients who receive 10 cc per kilogram body weight dextrose half saline as serum therapy during the surgery
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Imam Hossein hospital
Full name of responsible person
ََAmir Shafa
Street address
Imam Hossein hospital, Emam khomeini Blvd
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Email
shafa_amir@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayegh haghjooye javanmard
Street address
Vice-Chancellery for Research and Technology, Isfahan University of Medical science, Hezar Jerib Blvd
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
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
Negin Khavarian moghadam
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Milad dormitory, Medical university of Isfahan's dormitories, Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 87 3362 2634
Fax
Email
negin.khavarian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Negin Khavarian moghadam
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Milad dormitory, Medical university of Isfahan's dormitories, Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 87 3362 2634
Fax
Email
negin.khavarian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Negin Khavarian moghadam
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Milad dormitory, Medical university of Isfahan's dormitories, Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 87 3362 2634
Fax
Email
negin.khavarian@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...