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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting; Perioperative Body Temperature
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34093
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ASA1 group, 80 children, both sexes, aged 6 months to 7 years

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative 24 Hours

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: ISMAIL SUMER, MD, Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2019
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative nausea and vomiting; PONV; hypothermia; perioperative body tempreture
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: İsmail01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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