The Effect of Preoperative Oral Carbohydrate Administration on Perioperative Hypothermia in Pediatric Patients

May 20, 2024 updated by: Sevil Azazoglu ERBEK, Başakşehir Çam & Sakura City Hospital
Hypothermia that may develop in the perioperative period is associated with many adverse clinical outcomes. In particular, pediatric patients were more susceptible to hypothermia and related complications such as respiratory distress, metabolic acidosis, hypoglycemia, hypoxemia, cardiac disorders, coagulopathy, and wound infection than adults. In this study, the effect of preoperative carbohydrate-rich feeding on temperature regulation in pediatric patients was investigated.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Basaksehir Cam and Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Being between the ages of 2 and 15

Description

Inclusion Criteria:

  1. Patients to be operated on by the Department of Pediatric Surgery
  2. Being between the ages of 2 and 15
  3. Not restricting oral intake
  4. ASA I-II-III patients in anesthesia risk score
  5. Patients operated between 01.03.2019 and 31.07.2019
  6. Not having any communication problems (mental retardation, not knowing Turkish, etc.)
  7. Not having gastroesophageal reflux
  8. Not having any muscle disease
  9. Informed volunteer consent must be obtained
  10. Patients for whom emergency surgery is not planned
  11. No disease related to the central nervous system

Exclusion Criteria:

  1. Pediatric patients outside the 2-15 age range
  2. Having limited oral intake
  3. ASA IV and above in anesthesia risk scoring
  4. Patients operated before 01.03.2019 or after 31.07.2019
  5. Patients who may have communication problems with their parents or themselves
  6. Patients with gastroesophageal reflux
  7. Patients with muscle disease
  8. Patients for whom informed voluntary consent has not been obtained
  9. Patients who will undergo emergency surgery
  10. Patients with diseases related to the central nervous system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
GRUP W
patient group given only 5 ml kg-1 oral water 3 hours before the surgery,
GRUP C
Patient group given 5 ml kg-1 clear carbohydrate-rich liquid orally 3 hours before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effect of oral clear liquid intake containing carbohydrates 3 hours before preoperatively on body temperature in the pediatric age group, compared to the group taking water 3 hours before surgery.
Time Frame: 1 March 2019- 31 july 2019

In order to benefit from the thermic effects of nutrients, intravenous or oral administration of nutrients before or during the operation has been used. These include administering amino acid solutions and administering carbohydrate solutions Providing essential nutrients increases metabolic heat production, reducing the inequality between heat production and loss. The primary goal of this approach is to increase energy expenditure following the administration of essential nutrients, causing a response known as diet-induced thermogenesis.

The body temperatures of the patients were measured perioperative with a tympanic thermometer at regular intervals. Values lower than 36.0oC were considered as hypothermia.
1 March 2019- 31 july 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Başakşehir Çam & Sakura City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/64

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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