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OpenTrials
Completed

NCT Number: NCT06428604

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

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.

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Key information

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 24, 2024
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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