NCT04155931

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 7, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

October 30, 2019

Last Update Submit

June 26, 2020

Conditions

Keywords

perioperative body tempreturehypothermiaPONVPostoperative nausea and vomiting

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

Other: body temperature measurement

Interventions

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

body temperature measurement

Eligibility Criteria

Age6 Months - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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)

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingHypothermia

Interventions

Body Temperature

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomitingBody Temperature Changes

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysiological Phenomena

Study Officials

  • İsmail Sümer, MD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

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

Locations