## Protocol Section
### Identification Module
**NCT ID:** NCT06428604

**Brief Title:** The Effect of Preoperative Oral Carbohydrate Administration on Perioperative Hypothermia in Pediatric Patients

**Official Title:** The Effect of Preoperative Oral Carbohydrate Administration on Perioperative Hypothermia in Pediatric Patients

#### Organization Study ID Info
**ID:** 2019/64
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2019-07-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-07-31

**Type:** ACTUAL

#### Start Date
**Date:** 2019-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Başakşehir Çam & Sakura City Hospital

#### Responsible Party

**Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital

**Investigator Full Name:** Sevil Azazoglu ERBEK

**Investigator Title:** anesthesiologist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Perioperative Hypothermia

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Day

### Arms Interventions Module

#### Arm Group 1

**Description:** patient group given only 5 ml kg-1 oral water 3 hours before the surgery,

**Label:** GRUP W

#### Arm Group 2

**Description:** Patient group given 5 ml kg-1 clear carbohydrate-rich liquid orally 3 hours before surgery

**Label:** GRUP C

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 15 Years

**Minimum Age:** 2 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** Being between the ages of 2 and 15

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Başakşehir Çam and Sakura City Hospital

### References Module

#### References

**Citation:** Yatabe T, Kawano T, Yamashita K, Yokoyama M. Preoperative carbohydrate-rich beverage reduces hypothermia during general anesthesia in rats. J Anesth. 2011 Aug;25(4):558-62. doi: 10.1007/s00540-011-1170-z. Epub 2011 May 24.

**PMID:** 21607766

**Citation:** Dilmen OK, Yentur E, Tunali Y, Balci H, Bahar M. Does preoperative oral carbohydrate treatment reduce the postoperative surgical stress response in lumbar disc surgery? Clin Neurol Neurosurg. 2017 Feb;153:82-86. doi: 10.1016/j.clineuro.2016.12.016. Epub 2016 Dec 29.

**PMID:** 28073036

**Citation:** Castillo-Zamora C, Castillo-Peralta LA, Nava-Ocampo AA. Randomized trial comparing overnight preoperative fasting period Vs oral administration of apple juice at 06:00-06:30 am in pediatric orthopedic surgical patients. Paediatr Anaesth. 2005 Aug;15(8):638-42. doi: 10.1111/j.1460-9592.2005.01517.x.

**PMID:** 16033337

**Citation:** Carvalho CALB, Carvalho AA, Nogueira PLB, Aguilar-Nascimento JE. CHANGING PARADIGMS IN PREOPERATIVE FASTING: RESULTS OF A JOINT EFFORT IN PEDIATRIC SURGERY. Arq Bras Cir Dig. 2017 Jan-Mar;30(1):7-10. doi: 10.1590/0102-6720201700010003.

**PMID:** 28489159

**Citation:** Ozer AB, Demirel I, Kavak BS, Gurbuz O, Unlu S, Bayar MK, Erhan OL. Effects of preoperative oral carbohydrate solution intake on thermoregulation. Med Sci Monit. 2013 Jul 31;19:625-30. doi: 10.12659/MSM.883991.

**PMID:** 23900128

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001832

- Term: Body Temperature Changes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10085

- Name: Hypothermia

- Relevance: HIGH

- As Found: Hypothermia

- ID: M5111

- Name: Body Temperature Changes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007035

- Term: Hypothermia

### Misc Info Module

- Version Holder: 2024-05-31
