Evaluation of the effect of using two methods of fluid therapy with normal saline and one-fifth-four-fifth serum on plasma sodium and plasma glucose levels during and after neonatal surgery
Determining the effect of using two methods of fluid therapy with normal saline serum or one-fifth-four-fifth serum on plasma sodium and blood sugar levels during and after neonatal surgery
Design
Clinical trial without control group, with parallel, randomized groups
Settings and conduct
The present three-blind clinical trial study is performed on 72 1 to 30 day old infants in Imam Hossein Hospital, candidates for general anesthesia, using the same method. These patients are randomly divided into two groups of 36 patients. In the first group, patients receive fluid therapy with normal saline (10 cc/kg) and in the second group, patients receive one-fifth to four-fifths serum(10 cc/kg) . The plasma glucose level will be measured at baseline, every half hour during the operation, the end of the operation, immediately after entering the neonatal ward, and 2 hours after entering the ward. Sodium serum will be measured and recorded before entering the operating room and immediately after entering the neonatal intensive care unit and 2 hours after entering the ward.
Participants/Inclusion and exclusion criteria
Inclusion criteria include babies 1 day to 30 days old, candidates for surgery with the same general anesthesia protocol, American Society of Anesthesiologists Classification I and II. Exclusion criteria include disagreement of the patient's parents to participate in the study.
Intervention groups
All patients undergo general anesthesia in the same way and after intubation with the appropriate size and maintenance anesthesia with oxygen and Isoflurane anesthesia will be performed. Then, patients in the first intervention group will receive fluid therapy with normal saline (10 cc/kg) and in the second intervention group will receive fluid therapy with one-fifth-four-fifth serum (10 cc/kg).
Main outcome variables
Plasma sodium; Plasma Glucose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200411047035N1
Registration date:2020-09-10, 1399/06/20
Registration timing:registered_while_recruiting
Last update:2020-09-10, 1399/06/20
Update count:0
Registration date
2020-09-10, 1399/06/20
Registrant information
Name
Mina Azari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3665 1484
Email address
mina.azari10@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-31, 1399/06/10
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using two methods of fluid therapy with normal saline and one-fifth-four-fifth serum on plasma sodium and plasma glucose levels during and after neonatal surgery
Public title
Comparison of the effect of fluid therapy on plasma sodium and plasma glucose levels during and after neonatal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Babies 1 to 30 days old
Candidate for surgery with the same general anesthesia protocol
American Society of Anesthesiologists Classification I and II
Exclusion criteria:
Patient parents' disagreement to participate in the study
Age
From 1 day old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups of 36 using block randomization method of block size 4. So that four patients are randomly selected in the first block, then two of them will be simple randomly assigned to the control and the other two ones assigned to the intervention group. Again, another four patients will be randomly selected in the second block and two of them will be simple randomly assigned to the control and the other two ones assigned to the intervention group. This selection of blocks and assignment will be continued for 18 times to make the control or intervention groups of 36 ones.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, normal saline and one-fifth-four-fifth serum are prepared by the pharmacist and placed in coded packages and delivered daily to an anesthesiologist. They also prescribe them without knowing the type of any of the drugs. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.
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 Sciences, Hezar Jerib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-03-05, 1398/12/15
Ethics committee reference number
IR.MUI.MED.REC.1398.635
Health conditions studied
1
Description of health condition studied
Pediatric surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma sodiun levels
Timepoint
Sodium serum before entering the operating room and immediately after entering the neonatal intensive care unit and 2 hours after entering the intensive care unit
Method of measurement
Blood test
2
Description
Plasma glucose level
Timepoint
Blood sugar levels during baseline, every half hour during and after surgery, and immediately after entering the neonatal intensive care unit and 2 hours after entering the ward.
Method of measurement
Glucometer device
Secondary outcomes
empty
Intervention groups
1
Description
All patients undergo general anesthesia in the same way and after intubation with the appropriate size and maintenance anesthesia with oxygen and Isoflurane anesthesia will be performed. Then, patients in the first intervention group will receive fluid therapy with normal saline (10 cc/kg).
Category
Treatment - Other
2
Description
All patients undergo general anesthesia in the same way and after intubation with the appropriate size and maintenance anesthesia with oxygen and Isoflurane anesthesia will be performed. Then, patients in the second intervention group will receive fluid therapy with one-fifth-four-fifth serum (10 cc/kg)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam hossein Children's Hospital
Full name of responsible person
Amir Shafa
Street address
Emam Khomeyni
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3886 9141
Fax
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 Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
sh_haghjoo@med.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
Amir Shafa
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Street
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3886 9141
Email
shafa_amir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Amir Shafa
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini street
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3886 9141
Email
Shafa_amir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mina Azari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Mina.azari10@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD