Perioperative Body TemperatureNCT04155931
The Effect of Intraoperative Body Temperature on Postoperative Nausea and Vomiting in Pediatric Patients
An observational study of Perioperative Body Temperature and Postoperative Nausea and Vomiting, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to investigate the effects of changes in body temperature in the perioperative period on postoperative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 6 months to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Body Temperature, Postoperative Nausea and Vomiting
- What is being tested?
- body temperature measurement
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2019to 15 Mar 2020
- 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 6 months to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: ASA1 group, 80 children, both sexes, aged 6 months to 7 years
Who may be able to join
- ASA1 group
- Aged 6 months to 7 years
- lower abdominal and urological surgery
Who cannot join
- Upper abdominal surgery
- ASA 2-3 group
- postoperative nausea and vomiting history
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study was to investigate the effects of changes in body temperature in the perioperative period on postoperative nausea and vomiting.
Read the detailed description
Undesirable hypothermia is that the perioperative body temperature is below 36 ° C. Perioperative heat loss is higher in pediatric patients than in adult patients. One of the most common side effects of general anesthesia is nausea and vomiting. The aim of our study was to investigate the effects of changes in body temperature in the perioperative period on postoperative nausea and vomiting.We planned to perform prospectively in 80 children with ASA I according to the American Society of Anesthesia (ASA) Anesthesia Risk Scale between 6 months and 7 years of age in both sexes who underwent inguinal hernia, undescended testes and hydrocele surgery. In all patients, heating blanket was placed on the operation table and standard heat was used. After the placement of the LMA, a nasopharyngeal heat probe was placed for central body temperature measurement and monitored throughout the operation. Mean arterial pressure, heart rate and body temperature were recorded. Demographic data, type of operation, duration of operation and intraoperative fentanyl requirement of all cases were recorded. Analgesic and antiemetic requirements, presence of nausea and vomiting (according to numerical sequence scale) were recorded in the recovery room at 6, 12 and 24 hours postoperatively
- Being tested
- body temperature measurement
- Keywords
- perioperative body tempreture, hypothermia, PONV, Postoperative nausea and vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body temperature measurementOther
Postoperative analgesic and antiemetic requirements, nausea and vomiting were observed in the recovery room at 6, 12 and 24 hours
| Study group | Role | What they receive |
|---|---|---|
| body temperature measurement | The investigators planned to perform prospectively in 80 children with ASA I according to the American Society of Anesthesia (ASA) Anesthesia Risk Scale between 6 months and 7 years of age in both sexes who underwent inguinal hernia, undescended testes and hydrocele surgery Receives: Other: body temperature measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypothermia
Perioperative body temperature below 36 ° C is defined as unwanted hypothermia. It may cause postoperative neusea and vomiting.
Measured: intraoperative
Postoperative Nausea and vomiting
Postoperative analgesic and antiemetic requirements, nausea and vomiting were observed in the recovery room at 6, 12 and 24 hours.The investigators use numerical scale for posteoprative nausea and vomiting. 0-no nausea and vomiting, 1-nausea yes, vomiting no, 2- only 1 episode of vomiting and score3 is multiple vomiting episodes. if score is 1 or more than 1 we apllied antiemetics.
Measured: Postoperative 24 hours
Secondary outcomes (1)
Postoperative Pain
Postoperative analgesic and antiemetic requirements, nausea and vomiting were observed in the recovery room at 6, 12 and 24 hours. The investigators use pediatric objective pain scale.
Measured: Postoperative 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start7 Nov 2019
- Primary completion7 Feb 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Body TemperatureStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail SÜMER, Bezmialem Vakif University
- Investigators
- İsmail Sümer, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155931
- Sponsor's protocol ID
- İsmail01
- Status last verified
- Jun 2020
- First submitted
- 30 Oct 2019
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Body Temperature on Postoperative Nausea and Vomiting in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04155931
- Acronym / sponsor ID
- İsmail01
- Keywords
- perioperative body tempreture, hypothermia, PONV, Postoperative nausea and vomiting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 7 Nov 2019 (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.
The aim of our study was to investigate the effects of changes in body temperature in the perioperative period on postoperative nausea and vomiting.
Detailed description
Undesirable hypothermia is that the perioperative body temperature is below 36 ° C. Perioperative heat loss is higher in pediatric patients than in adult patients. One of the most common side effects of general anesthesia is nausea and vomiting. The aim of our study was to investigate the effects of changes in body temperature in the perioperative period on postoperative nausea and vomiting.We planned to perform prospectively in 80 children with ASA I according to the American Society of Anesthesia (ASA) Anesthesia Risk Scale between 6 months and 7 years of age in both sexes who underwent inguinal hernia, undescended testes and hydrocele surgery. In all patients, heating blanket was placed on the operation table and standard heat was used. After the placement of the LMA, a nasopharyngeal heat probe was placed for central body temperature measurement and monitored throughout the operation. Mean arterial pressure, heart rate and body temperature were recorded. Demographic data, type of operation, duration of operation and intraoperative fentanyl requirement of all cases were recorded. Analgesic and antiemetic requirements, presence of nausea and vomiting (according to numerical sequence scale) were recorded in the recovery room at 6, 12 and 24 hours postoperatively
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| body temperature measurement | – | Other: body temperature measurementThe investigators planned to perform prospectively in 80 children with ASA I according to the American Society of Anesthesia (ASA) Anesthesia Risk Scale between 6 months and 7 years of age in both sexes who underwent inguinal hernia, undescended testes and hydrocele surgery |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- ASA1 group, 80 children, both sexes, aged 6 months to 7 years
Key inclusion criteria (3 listed)
- ASA1 group
- Aged 6 months to 7 years
- lower abdominal and urological surgery
Key exclusion criteria (3 listed)
- Upper abdominal surgery
- ASA 2-3 group
- postoperative nausea and vomiting history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| body temperature measurementPostoperative analgesic and antiemetic requirements, nausea and vomiting were observed in the recovery room at 6, 12 and 24 hours | Other | body temperature measurement |
Primary outcome
hypothermia
Time frame: intraoperative
Perioperative body temperature below 36 ° C is defined as unwanted hypothermia. It may cause postoperative neusea and vomiting.
Postoperative Nausea and vomiting
Time frame: Postoperative 24 hours
Postoperative analgesic and antiemetic requirements, nausea and vomiting were observed in the recovery room at 6, 12 and 24 hours.The investigators use numerical scale for posteoprative nausea and vomiting. 0-no nausea and vomiting, 1-nausea yes, vomiting no, 2- only 1 episode of vomiting and score3 is multiple vomiting episodes. if score is 1 or more than 1 we apllied antiemetics.
1 secondary outcome
Postoperative Pain
Time frame: Postoperative 24 Hours
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 29 Jun 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Perioperative Body Temperature
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Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
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Goal-Directed Temperature Management During Prolonged Abdominal Surgery
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Agreement Among Three Methods of Intraoperative Core Temperature Monitoring: Nasopharyngeal Probe, TaiDoc TD-1261 Infrared Tympanic Thermometer, and 3M SpotOn™ Skin Sensor
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Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases
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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.
İsmail Sümer, MD principal investigator
Bezmialem Vakif University
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 Body Temperature and Postoperative Nausea and Vomiting, run by Bezmialem Vakif University 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 3 inclusion and 3 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 29 Jun 2020. 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?
hypothermia (time frame: intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2020.