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Trial Title:
RL Versus Glucose Saline in Cancer Patient Undergoing Major Surgeries and Its Impact on Electrolytes, GLC & pH
NCT ID:
NCT05810662
Condition:
Fluid and Electrolyte Imbalance
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Lactated ringer and dextrose 5%
Description:
Fluid use perioperative
Arm group label:
5%dextrose in 0.9%saline
Arm group label:
Ringer lactate
Summary:
To compare two electrolytes maintenance in perioperative period in children undergoing
major surgeries on perioperative change in pH,lactate,sodium and glucose level
Detailed description:
Patients were randomized into 2 groups ringer lactate versus 5%dextrose in 0.9%
saline,using a computer generated random list in blocks of 4 after recruitment the
enrolling investigators opened sealed opaque envelopes that concealed group allocation
participants ,trial investigators,attending anesthetist providing general anesthesia for
the cases and the outcomes were blinded to group allocation
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 1to 10 years Children undergoing major surgeries ie considered major if any invasive
procedure in which extensive resection will be preformed e.g body cavity is
opened,organs are removed and normal anatomy is altered abd duration not less than 2
hours or more than 5 hours.
Exclusion Criteria:
- patient guardian refusal
_ Children with documented endocrine distrubances(DM,inborn error of
metabolism,hyperthyroidism)
- age less than one year
- preexisting renal disease,hepatic disease and patien suffering from heart failure.
- preexisting electrolyte imbalance (normal sodium level 135-145)
Gender:
All
Minimum age:
1 Year
Maximum age:
10 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer institute
Address:
City:
Cairo
Country:
Egypt
Start date:
September 4, 2022
Completion date:
December 2023
Lead sponsor:
Agency:
National Cancer Institute, Egypt
Agency class:
Other
Source:
National Cancer Institute, Egypt
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05810662
