Comparison of administration of oral dextrose with intravenous infusion of 1/3 2/3 serum, on the incidence of hypoglycemia in children 2-6 years old candidate for minor surgery under general anesthesia
Investigation of blood sugar changes during minor surgery in two to six-year-old children in two groups of oral administration of sugar or continuous intravenous injection of serum 1/3 2/3.
Design
Randomized clinical trial with randomized double-blind randomized groups on 66 patients with SPSS software
Settings and conduct
Group I included children who had npo after midnight for surgery the next morning, and during the npo period, serum 1/3 2/3 was infused according to the formula for calculating the amount of maintenance fluid until the operation. Group II included those who received 10 ml per kg body weight of 5% glucose two hours before the start of surgery.
The first glucose was checked after induction of anesthesia and the second glucose was checked 30 minutes after inductionof anesthesia. Hypoglycemia was defined as hypoglycemia less than 50mg/kg and hyperglycemia was defined as hypoglycemia above 150mg/dl.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 2-6 years old, candidate for minor surgery under general anesthesia.
Exclusion criteria: Diabetic patients, Patients with a history of hypoglycemia, Metabolic diseases, and History of seizures.
Intervention groups
Group one: Patients receiving serum 1/3 2/3.
Group Two: Patients receiving oral sugar.
Main outcome variables
Measurement of blood sugar every half hour after surgery begins to the end of the operation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220523054970N1
Registration date:2023-03-29, 1402/01/09
Registration timing:retrospective
Last update:2023-03-29, 1402/01/09
Update count:0
Registration date
2023-03-29, 1402/01/09
Registrant information
Name
Kaveh Latifinaibin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4427 5434
Email address
dr.latifikaveh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-09-22, 1399/07/01
Trial completion date
2020-09-22, 1399/07/01
Scientific title
Comparison of administration of oral dextrose with intravenous infusion of 1/3 2/3 serum, on the incidence of hypoglycemia in children 2-6 years old candidate for minor surgery under general anesthesia
Public title
Comparison of administration of oral dextrose with intravenous infusion of 1/3 2/3 serum, on the incidence of hypoglycemia
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Children 2-6 years old, candidate for minor surgery under general anesthesia
Exclusion criteria:
Diabetic patients
Patients with a history of hypoglycemia
Metabolic diseases
History of seizures
Age
From 2 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
66
Actual sample size reached:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In this intervention study, which was conducted as a randomized clinical trial, the study subjects were selected based on a simple random table. To use the table of random numbers, we first defined the framework of our statistical society; That is, the exact number of people in the society was known and they were assigned a code respectively. To select sample people from the table, it was randomly started from a point of the table in the direction of row or column. The selected number was actually the code of an individual from the community that is selected as a sample.
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthetic technicians of the patients who checked their blood sugar and then the note were unaware of the type of intervention. Patients also did not understand the type of clinical intervention due to their young age.
Placebo
Not used
Assignment
Parallel
Other design features
No study has been conducted in this field in Iran.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran Hemat Highway next to Milad Tower، 14535
City
Tehran
Province
Tehran
Postal code
14535
Approval date
2019-11-19, 1398/08/28
Ethics committee reference number
IR.IUMS.FMD.REC.1398.355
Health conditions studied
1
Description of health condition studied
Hypoglycemia
ICD-10 code
E16.2
ICD-10 code description
Hypoglycaemia, unspecified
Primary outcomes
1
Description
Reducing the incidence of hypoglycemia and its complications
Timepoint
The blood glucose was checked first after the induction and the second blood glucose was checked after 30 minutes of induction
Method of measurement
Blood glucose was measured using a glucometer sensor.
2
Description
Hypoglycemia was defined as blood glucose less than 50 mg / kg and hyperglycemia was defined as blood glucose above 150 mg / dl.
Timepoint
The blood glucose was checked first after the induction and the second blood glucose was checked after 30 minutes of induction
Method of measurement
Blood glucose was measured using a glucometer sensor.
Secondary outcomes
1
Description
Hemodynamics including heart rate, systolic blood pressure and mean arterial pressure (MAP)
Timepoint
before induction of anesthesia and every 5 minutes to 20 minutes thereafter
Method of measurement
Based on blood pressure cuff
Intervention groups
1
Description
The first intervention group: included patients who were fasting after midnight for surgery the next morning, and during the fasting period, maintenance 1/3 2/3 serum was calculated at 5 ml/kg per hour and was infused until the time of surgery.
Category
Other
2
Description
Intervention group: The second intervention group: this group included patients who received oral 5% glucose 10 ml/kg two hours before surgery.