Pediatric Surgery Clinical Trial
Official title:
Effect of Using Dextrose-containing Intraoperative Fluid in Children: a Randomized Controlled Trial
The glucose-containing fluid was preferred for maintenance fluid in pediatric surgery to prevent hypoglycemic events. This practice can lead to intraoperative hyperglycemia which can induce osmotic diuresis and consequently dehydration and electrolyte disturbances. As an anesthesiologist, the use of glucose-containing fluid should be reconsidered to avoid these undesirable effects in pediatric surgery. Our study aims to identify an appropriate use of 5% dextrose containing solution during intraoperative period in children (2 age groups: 1-2 vs 3-5 years old) that can prevent glucose and lipid mobilization without causing hypo/hyperglycemia and provide adequate fluid maintenance in the context of hospitals in Thailand
Status | Not yet recruiting |
Enrollment | 68 |
Est. completion date | December 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 5 Years |
Eligibility | Inclusion Criteria: 1. Children aged of 1 to 5 years 2. ASA physical status 1 and 2 3. Schedule for elective non-abdominal surgery between 1-3 hours under general anesthesia without anticipation of major blood loss at Siriraj Hospital. Exclusion Criteria: 1. Patients with severe neurologic, cardiac, endocrine, or metabolic disease 2. Patients receiving intravenous fluid preoperatively 3. Patients with history or have known risk of hypoglycemia 4. Patient with severe liver dysfunction Withdrawal or termination criteria 1. Patients requiring intraoperative blood product transfusion or inotropes infusion 2. Patients who have preoperative hypoglycemia |
Country | Name | City | State |
---|---|---|---|
Thailand | Siriraj Hospital | Bangkok noi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Barua K, Rajan S, Paul J, Tosh P, Padmalayan A, Kumar L. Effect of Using Ringer's Lactate, with and without Addition of Dextrose, on Intra-Operative Blood Sugar Levels in Infants Undergoing Facial Cleft Surgeries. Anesth Essays Res. 2018 Apr-Jun;12(2):297-301. doi: 10.4103/aer.AER_53_18. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The difference in pre and postoperative value of base excess | To find the difference in pre and postoperative value of base excess among the different fluid groups which is an acid-base parameter indicating volume status and mobilization of lipid stores in each age group. | 1 day | |
Secondary | The difference in postoperative value of other acid-base, metabolic, and endocrine parameters | To find the difference in postoperative value of other acid-base, metabolic, and endocrine parameters that indicate mobilization of glucose and lipid stores of each group with different maintenance rate of fluid in each age group and between age group. | 1 day | |
Secondary | Incidence of postoperative base excess value that equal or more negative than -5 of each group | To find the incidence of postoperative base excess value that equal or more negative than -5 of each group with different maintenance rate of fluid in each age group and between age group. | 1 day | |
Secondary | The difference in perioperative blood glucose level among the groups | To find the difference in perioperative blood glucose level among the groups measured during surgery of each group with different maintenance rate of fluid in each age group and between age group. | 1 day | |
Secondary | Incidence of hypotension of each group | To find the incidence of hypotension of each group with different maintenance rate of fluid in each age group and between age group | 1 day |
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