RL Versus Glucose Saline in Cancer Patient Undergoing Major Surgeries and Its Impact on Electrolytes, GLC & pH

Fluid and Electrolyte Imbalance Clinical Trial

Official title:

Randomized Study of Intraoperative Glucose Saline Versus Ringer Lactatein Cancer Pediatric Patients Doing Major Surgeries and Impact on Electrolytes ,Glucose and pH

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05810662
• Other study ID #: AP1907-30106
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 4, 2022
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare two electrolytes maintenance in perioperative period in children undergoing major surgeries on perioperative change in pH,lactate,sodium and glucose level

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fluid and Electrolyte Imbalance

Intervention

Other:
• Lactated ringer and dextrose 5%
Fluid use perioperative

Locations

Country	Name	City	State
Egypt	National Cancer institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PH and lactate level	Three ABG will be collected from the patient. The first at start before any intervention,the second after start of replacement and the third at the end of the operation.	In the introperative period
Secondary	Sodium and glucose level	Three ABGs will be collected.The first at the start of the operation before any surgical intervention,the second after the start of fluid replacement and the last sample at the end of the operation.	The intraoperative period