Heart Rate Variability and Postoperative Nausea Vomiting

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT04514211
Collaborator
(none)
40
1
14.5
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Different types of anesthetics have different effects on heart rate variability. However It has not yet been reported whether this difference in effect remains at recovery time after anesthesia.

Several studies have been reported that preoperative heart rate variability predicted the occurence of postoperative nausea and vomiting. However, whether the difference in heart rate variability after anesthesia is related to the difference in postoperative nausea and vomiting has not been studied. Therefore, this study aims to observe whether propofol and sevoflurane have differences during recovery period after anesthesia in heart rate variabiliy. In addition, we want to examine that these differences during recovery period in heart rate variability can predict the occurrence of nausea and vomiting within 24 hours after surgery.

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effects of Propofol and Sevoflurane on Postoperative Heart Rate Variability and Postoperative Nausea Vomiting
Actual Study Start Date :
Oct 17, 2020
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Propofol

General anesthesia using propofol infusion

Drug: Propofol
General anesthesia using propofol infusion
Other Names:
  • Propofol infusion
  • Sevoflurane

    General anesthesia using sevoflurane

    Drug: Sevoflurane
    General anesthesia using sevoflurane
    Other Names:
  • Sevoflurane inhalation
  • Outcome Measures

    Primary Outcome Measures

    1. heart rate variability in recovery room [within 1 hour]

      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

    Secondary Outcome Measures

    1. Postoperative nausea vomiting impact scale [48 hours after anesthesia]

      Q1. Have you vomited or had dry-retching? 0. No Once twice 3 or more times Q2. Have you experienced a feeling of nausea? If yes, has your feeling of nausea interfered with activities of daily living? 0. not at all Sometimes often or most of the time All of the time Add the numerical responses to questions 1 and 2. (total score 0~6)

    2. The incidence of postoperative nausea and vomiting [48 hours after anesthesia]

      the time of occurence

    3. Patient's satisfaction about postoperative nausea and vomiting [48 hours after anesthesia]

      verbal rating scale (0~10), 0=very unsatisfied, 10=very satisfied

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Scheduled breast surgery under general anesthesia
    Exclusion Criteria:
    • Arrhythmia

    • Uncooperative with the measuring heart rate variability

    • Diabetes

    • Hypertension on medication

    • Patients taking psychiatric drugs

    • Thyroid disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ajou university school of medicine Suwon Gyeonggi-do Korea, Republic of 16499

    Sponsors and Collaborators

    • Ajou University School of Medicine

    Investigators

    • Principal Investigator: In Kyong Yi, MD, Ajou University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    In-kyong Yi, assistant professor, Ajou University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT04514211
    Other Study ID Numbers:
    • AJIRB-MED-OBS-20-293
    First Posted:
    Aug 14, 2020
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by In-kyong Yi, assistant professor, Ajou University School of Medicine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 18, 2022