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Completed

NCT Number: NCT04514211

Heart Rate Variability and Postoperative Nausea Vomiting

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.

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Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

General anesthesia using propofol infusion

Other names: Propofol infusion

Sevoflurane

Drug

General anesthesia using sevoflurane

Other names: Sevoflurane inhalation

Primary outcomes

  1. heart rate variability in recovery room

    Time frame: 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 outcomes

  1. Postoperative nausea vomiting impact scale

    Time frame: 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

    Time frame: 48 hours after anesthesia

    the time of occurence

  3. Patient's satisfaction about postoperative nausea and vomiting

    Time frame: 48 hours after anesthesia

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

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

The Effects of Propofol and Sevoflurane on Postoperative Heart Rate Variability and Postoperative Nausea Vomiting

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 14, 2020
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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