Postoperative Nausea and VomitingNCT04514211
Heart Rate Variability and Postoperative Nausea Vomiting
An observational study of Postoperative Nausea and Vomiting, run by Ajou University School of Medicine at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Oct 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: 20~50 years old female patients who scheduled breast surgery under general anesthesia
Who may be able to join
- Scheduled breast surgery under general anesthesia
Who cannot join
- Arrhythmia
- Uncooperative with the measuring heart rate variability
- Diabetes
- Hypertension on medication
- Patients taking psychiatric drugs
- Thyroid disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou university school of medicine
Suwon, Gyeonggi-do, 16499
About this study
Official title: The Effects of Propofol and Sevoflurane on Postoperative 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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Propofol, Sevoflurane
- Keywords
- postoperative nausea and vomiting, heart rate variability, propofol, sevoflurane
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Propofol infusion
General anesthesia using propofol infusion
SevofluraneDrug
Also called Sevoflurane inhalation
General anesthesia using sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Propofol | General anesthesia using propofol infusion Receives: Drug: Propofol | |
| Sevoflurane | General anesthesia using sevoflurane Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 1 hour
Secondary outcomes (3)
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)
Measured: 48 hours after anesthesia
The incidence of postoperative nausea and vomiting
the time of occurence
Measured: 48 hours after anesthesia
Patient's satisfaction about postoperative nausea and vomiting
verbal rating scale (0~10), 0=very unsatisfied, 10=very satisfied
Measured: 48 hours after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start17 Oct 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-kyong Yi, Ajou University School of Medicine
- Investigators
- In Kyong Yi, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514211
- Sponsor's protocol ID
- AJIRB-MED-OBS-20-293
- Status last verified
- Feb 2022
- First submitted
- 12 Aug 2020
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will provide it upon the reasonable personal request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Propofol and Sevoflurane on Postoperative Heart Rate Variability and Postoperative Nausea Vomiting
- ClinicalTrials.gov ID
- NCT04514211
- Acronym / sponsor ID
- AJIRB-MED-OBS-20-293
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- postoperative nausea and vomiting, heart rate variability, propofol, sevoflurane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | – | Drug: PropofolGeneral anesthesia using propofol infusion |
| Sevoflurane | – | Drug: SevofluraneGeneral anesthesia using sevoflurane |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 20~50 years old female patients who scheduled breast surgery under general anesthesia
Key inclusion criteria (1 listed)
- Scheduled breast surgery under general anesthesia
Key exclusion criteria (6 listed)
- Arrhythmia
- Uncooperative with the measuring heart rate variability
- Diabetes
- Hypertension on medication
- Patients taking psychiatric drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: Propofol infusionGeneral anesthesia using propofol infusion | Drug | Propofol |
| SevofluraneAlso: Sevoflurane inhalationGeneral anesthesia using sevoflurane | Drug | Sevoflurane |
Primary outcome
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
3 secondary outcomes
Postoperative nausea vomiting impact scale
Time frame: 48 hours after anesthesia
The incidence of postoperative nausea and vomiting
Time frame: 48 hours after anesthesia
Patient's satisfaction about postoperative nausea and vomiting
Time frame: 48 hours after anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: Undecided. We will provide it upon the reasonable personal request.
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Kyong Yi, MD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Nausea and Vomiting, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability in recovery room (time frame: within 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.