The Effect of Intraoperative Body Temperature on Postoperative Nausea and Vomiting in Pediatric Patients
1 other identifier
observational
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2019
CompletedFirst Posted
Study publicly available on registry
November 7, 2019
CompletedStudy Start
First participant enrolled
November 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2020
CompletedJune 29, 2020
June 1, 2020
3 months
October 30, 2019
June 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
hypothermia
Perioperative body temperature below 36 ° C is defined as unwanted hypothermia. It may cause postoperative neusea and vomiting.
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.
Postoperative 24 hours
Secondary Outcomes (1)
Postoperative Pain
Postoperative 24 Hours
Study Arms (1)
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
Interventions
Postoperative analgesic and antiemetic requirements, nausea and vomiting were observed in the recovery room at 6, 12 and 24 hours
Eligibility Criteria
ASA1 group, 80 children, both sexes, aged 6 months to 7 years
You may qualify if:
- ASA1 group
- Aged 6 months to 7 years
- lower abdominal and urological surgery
You may not qualify if:
- Upper abdominal surgery
- ASA 2-3 group
- postoperative nausea and vomiting history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif University
Istanbul, 34093, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
İsmail Sümer, MD
Bezmialem Vakif University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Principal Investigator
Study Record Dates
First Submitted
October 30, 2019
First Posted
November 7, 2019
Study Start
November 7, 2019
Primary Completion
February 7, 2020
Study Completion
March 15, 2020
Last Updated
June 29, 2020
Record last verified: 2020-06