Heart Rate Variability and Postoperative Nausea Vomiting

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Propofol; Drug: Sevoflurane

• Registration Number: NCT04514211
• Lead Sponsor: Ajou University School of Medicine

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.

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 Timeline

• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-14
• Study Start: 2020-10-17
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	General anesthesia using propofol infusion
Sevoflurane	Sevoflurane	General anesthesia using sevoflurane

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Patient's satisfaction about postoperative nausea and vomiting	48 hours after anesthesia	verbal rating scale (0\~10), 0=very unsatisfied, 10=very satisfied
Postoperative nausea vomiting impact scale	48 hours after anesthesia	Q1. Have you vomited or had dry-retching? 0. No; 1. Once; 2. twice; 3. 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; 1. Sometimes; 2. often or most of the time; 3. All of the time; Add the numerical responses to questions 1 and 2. (total score 0\~6)
The incidence of postoperative nausea and vomiting	48 hours after anesthesia	the time of occurence

Trial Locations

Locations (1)

Ajou university school of medicine; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of