NCT04514211

Brief Summary

Propofol and sevoflurane have different effects on heart rate variability. It has not yet been reported whether this difference in effect remains at recovery time after anesthesia and the difference is related to postoperative nausea and vomiting has not been studied. The aim of this study is observe whether propofol and sevoflurane have different effects on heart rate variability during recovery and the differences can predict the occurrence of postoperative nausea and vomiting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 17, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

August 12, 2020

Last Update Submit

February 16, 2022

Conditions

Keywords

postoperative nausea and vomitingheart rate variabilitypropofolsevoflurane

Outcome Measures

Primary Outcomes (1)

  • heart rate variability in recovery room

    Postoperative heart rate variability measuring at recovery room Frequency domain result: total power, low frequency power, high frequency power, Low frequency/high frequency power ratio

    within 1 hour

Secondary Outcomes (3)

  • Postoperative nausea vomiting impact scale

    48 hours after anesthesia

  • The incidence of postoperative nausea and vomiting

    48 hours after anesthesia

  • Patient's satisfaction about postoperative nausea and vomiting

    48 hours after anesthesia

Study Arms (2)

Propofol

General anesthesia using propofol infusion

Drug: Propofol

Sevoflurane

General anesthesia using sevoflurane

Drug: Sevoflurane

Interventions

General anesthesia using propofol infusion

Also known as: Propofol infusion
Propofol

General anesthesia using sevoflurane

Also known as: Sevoflurane inhalation
Sevoflurane

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsInclude only mathces self-representation of gender identity and biological sex
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

20\~50 years old female patients who scheduled breast surgery under general anesthesia

You may qualify if:

  • Scheduled breast surgery under general anesthesia

You may not qualify if:

  • Arrhythmia
  • Uncooperative with the measuring heart rate variability
  • Diabetes
  • Hypertension on medication
  • Patients taking psychiatric drugs
  • Thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • In Kyong Yi, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 14, 2020

Study Start

October 17, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations