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

NCT ID: NCT06428604

Last Updated: 2024-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Perioperative Hypothermia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GRUP W

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

No interventions assigned to this group

GRUP C

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sevil Azazoglu ERBEK

anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Başakşehir Çam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21607766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28073036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16033337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28489159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23900128 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019/64

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.