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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04155931
Other study ID # Ismail01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 7, 2019
Est. completion date March 15, 2020

Study information

Verified date June 2020
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 15, 2020
Est. primary completion date February 7, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 7 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary hypothermia Perioperative body temperature below 36 ° C is defined as unwanted hypothermia. It may cause postoperative neusea and vomiting. intraoperative
Primary 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 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
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