Perioperative HypothermiaNCT06428604
The Effect of Preoperative Oral Carbohydrate Administration on Perioperative Hypothermia in Pediatric Patients
An observational study of Perioperative Hypothermia, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Perioperative Hypothermia
- Type of treatment
- Pill or oral medicine
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 31 Jul 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- Child
Study population: Being between the ages of 2 and 15
Who may be able to join
- 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.)
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul
About this study
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
- Perioperative Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 1 March 2019- 31 july 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Mar 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Perioperative HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sevil Azazoglu ERBEK, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428604
- Sponsor's protocol ID
- 2019/64
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21607766Dilmen 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.
PubMed 28073036Castillo-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.
PubMed 16033337Carvalho 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.
PubMed 28489159Ozer 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.
PubMed 23900128
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Oral Carbohydrate Administration on Perioperative Hypothermia in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06428604
- Acronym / sponsor ID
- 2019/64
- Conditions
- Perioperative Hypothermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Being between the ages of 2 and 15
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Background: PubMed 21607766Yatabe 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.
- Background: PubMed 28073036Dilmen 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.
- Background: PubMed 16033337Castillo-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.
- Background: PubMed 28489159Carvalho 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.
- Background: PubMed 23900128Ozer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Hypothermia, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06428604, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.