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Completed

NCT Number: NCT04155931

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

The aim of our study was to investigate the effects of changes in body temperature in the perioperative period on postoperative nausea and vomiting.

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Key information

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

body temperature measurement

Other

Postoperative analgesic and antiemetic requirements, nausea and vomiting were observed in the recovery room at 6, 12 and 24 hours

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2019
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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