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

Not Applicable

Active, not recruiting

• Conditions: Fluid and Electrolyte Imbalance
• Interventions: Other: Lactated ringer and dextrose 5%

• Registration Number: NCT05810662
• Lead Sponsor: National Cancer Institute, Egypt

Brief 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

Study Timeline

• Study Start: 2022-09-04
• Status Verified: 2023-03
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Last Update Submitted: 2023-03-31
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12
• Primary Completion: 2023-08
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer lactate	Lactated ringer and dextrose 5%	Ringer's lactate solution, or lactated Ringer's solution, is a type of isotonic, crystalloid fluid further classified as a balanced or buffered solution used for fluid replacement. The contents of Ringer's lactate include sodium, chloride, potassium, calcium, and lactate in the form of sodium lactate, mixed into a solution with an osmolarity of 273 mOsm/L and pH of about 6.5.
5%dextrose in 0.9%saline	Lactated ringer and dextrose 5%	5% Dextrose and 0.45% Sodium Chloride Injection, USP solution is sterile and nonpyrogenic. It is a large volume parenteral solution containing dextrose and sodium chloride in water for injection intended for intravenous administration. Each 100 mL of 5% Dextrose and 0.45% Sodium Chloride Injection, USP contains dextrose, hydrous 5 g and sodium chloride 0.45 g in water for injection. Electrolytes per 1000 mL: sodium (Na+), 77 mEq; chloride (Cl-) 77 mEq. The osmolarity is 406 mOsmol/L (calc.), which is hypertonic. The caloric value is 170 kcal/L. The pH is 4.3 (3.5 to 6.5). 5% Dextrose and 0.45% Sodium Chloride Injection, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection.

Primary Outcome Measures

Name	Time	Method
PH and lactate level	In the introperative period	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.

Secondary Outcome Measures

Name	Time	Method
Sodium and glucose level	The intraoperative period	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.

Trial Locations

Locations (1)

National Cancer institute; 🇪🇬 Cairo, Egypt