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

Sponsor
National Cancer Institute, Egypt (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05810662
Collaborator
(none)
60
1
2
14.9
4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Lactated ringer and dextrose 5%
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Randomized Study of Intraoperative Glucose Saline Versus Ringer Lactatein Cancer Pediatric Patients Doing Major Surgeries and Impact on Electrolytes ,Glucose and pH
Actual Study Start Date :
Sep 4, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Other: Lactated ringer and dextrose 5%
Fluid use perioperative

Active Comparator: 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.

Other: Lactated ringer and dextrose 5%
Fluid use perioperative

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cancer institute Cairo Egypt

Sponsors and Collaborators

  • National Cancer Institute, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mona Mohammed Atteya, Anesthesia specialist, National Cancer Institute, Egypt
ClinicalTrials.gov Identifier:
NCT05810662
Other Study ID Numbers:
  • AP1907-30106
First Posted:
Apr 12, 2023
Last Update Posted:
Apr 12, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 12, 2023