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

NCT ID: NCT05810662

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-04
• Study Completion Date: 2023-12-31

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

Conditions

Fluid and Electrolyte Imbalance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Ringer lactate

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.

Group Type: ACTIVE_COMPARATOR

Lactated ringer and dextrose 5%

Intervention Type: OTHER

Fluid use perioperative

5%dextrose in 0.9%saline

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.

Group Type: ACTIVE_COMPARATOR

Lactated ringer and dextrose 5%

Intervention Type: OTHER

Fluid use perioperative

Interventions

Lactated ringer and dextrose 5%

Fluid use perioperative

Intervention Type: OTHER

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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Mona Mohammed Atteya

Anesthesia specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cancer institute

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AP1907-30106

Identifier Type: -

Identifier Source: org_study_id