Heart Rate Variability and Postoperative Nausea Vomiting

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514211
• Other study ID #: AJIRB-MED-OBS-20-293
• Status: Completed
• Start date: October 17, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Propofol
General anesthesia using propofol infusion
• Sevoflurane
General anesthesia using sevoflurane

Locations

Country	Name	City	State
Korea, Republic of	Ajou university school of medicine	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative nausea vomiting impact scale	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)	48 hours after anesthesia
Secondary	The incidence of postoperative nausea and vomiting	the time of occurence	48 hours after anesthesia
Secondary	Patient's satisfaction about postoperative nausea and vomiting	verbal rating scale (0~10), 0=very unsatisfied, 10=very satisfied	48 hours after anesthesia