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The Effect of Intraoperative Body Temperature on Postoperative Nausea and Vomiting in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT04155931
Recruitment Status : Completed
First Posted : November 7, 2019
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
İsmail SÜMER, Bezmialem Vakif University

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.

Condition or disease Intervention/treatment
Perioperative Body Temperature Postoperative Nausea and Vomiting Other: body temperature measurement

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: The Effect of Intraoperative Body Temperature on Postoperative Nausea and Vomiting in Pediatric Patients
Actual Study Start Date : November 7, 2019
Actual Primary Completion Date : February 7, 2020
Actual Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Other: body temperature measurement
Postoperative analgesic and antiemetic requirements, nausea and vomiting were observed in the recovery room at 6, 12 and 24 hours




Primary Outcome Measures :
  1. hypothermia [ Time Frame: intraoperative ]
    Perioperative body temperature below 36 ° C is defined as unwanted hypothermia. It may cause postoperative neusea and vomiting.

  2. 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.


Secondary Outcome Measures :
  1. Postoperative Pain [ 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 pediatric objective pain scale.



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Ages Eligible for Study:   6 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
ASA1 group, 80 children, both sexes, aged 6 months to 7 years
Criteria

Inclusion Criteria:

  • ASA1 group
  • Aged 6 months to 7 years
  • lower abdominal and urological surgery

Exclusion Criteria:

  • Upper abdominal surgery
  • ASA 2-3 group
  • postoperative nausea and vomiting history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155931


Locations
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Turkey
Bezmialem Vakif University
İstanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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Principal Investigator: İsmail Sümer, MD Bezmialem Vakif University
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Responsible Party: İsmail SÜMER, MD, Principal Investigator, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04155931    
Other Study ID Numbers: İsmail01
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by İsmail SÜMER, Bezmialem Vakif University:
perioperative body tempreture
hypothermia
PONV
Postoperative nausea and vomiting
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes