Postoperative Nausea and Vomiting (PONV)NCT06948708
Predictive Role of HRV for PONV in Laparoscopic Cholecystectomy
An observational study of Postoperative Nausea and Vomiting (PONV) and Heart Rate Variability (HRV), run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative nausea and vomiting (PONV) are among the most common complications following general anesthesia (GA), significantly affecting patient comfort and recovery. Although various risk factors for PONV have been identified-such as female sex, non-smoking status, and history of motion sickness-these predictors… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting (PONV), Heart Rate Variability (HRV), Laparoscopic Cholecystectomy
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2025to 15 Sep 2025
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients aged 18-65 years, scheduled for elective laparoscopic cholecystectomy under general anesthesia at a tertiary care hospital.
Who may be able to join
- Female patients aged 18 to 65 years
- Scheduled for elective laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) physical status I
- Body mass index (BMI) < 35 kg/m²
- Non-smokers
- Able and willing to provide written informed consent
Who cannot join
- History of cardiovascular, neurological, or gastrointestinal disease
- Use of medications affecting HRV (e.g., antihypertensives, diuretics, atropine, antidepressants, antipsychotics, steroids)
- Presence of systemic diseases that may affect PONV risk
- Inability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Predictive Role of Heart Rate Variability in Postoperative Nausea and Vomiting Among Female Patients Undergoing Elective Laparoscopic Cholecystectomy: A Prospective Observational Study
Postoperative nausea and vomiting (PONV) are among the most common complications following general anesthesia (GA), significantly affecting patient comfort and recovery. Although various risk factors for PONV have been identified-such as female sex, non-smoking status, and history of motion sickness-these predictors are not always sufficient to determine individual risk accurately.
Heart rate variability (HRV) reflects autonomic nervous system (ANS) balance and has been proposed as a potential physiological biomarker for predicting PONV. Reduced HRV is associated with increased vagal imbalance, which may contribute to gastrointestinal (GI) dysregulation and PONV.
Read more
This prospective observational study aims to investigate the predictive value of HRV in estimating the incidence and severity of PONV in female patients undergoing elective laparoscopic cholecystectomy (LC). A total of 110 participants will be enrolled, and preoperative and early postoperative HRV measurements will be obtained using a validated chest-strap heart rate monitor (Polar H10). HRV parameters, including the standard deviation of normal-to-normal intervals (SDNN), the root mean square of successive differences (RMSSD), and the low-frequency/high-frequency (LF/HF) ratio, will be analyzed via the Elite HRV application. Standardized anesthesia, analgesia, and antiemetic protocols will be used for all participants. PONV severity will be assessed over the first 24 hours postoperatively using a 4-point scale.
The primary objective is to evaluate whether preoperative HRV can predict PONV occurrence. Secondary outcomes include correlations between HRV parameters and PONV severity.
- Conditions
- Postoperative Nausea and Vomiting (PONV), Heart Rate Variability (HRV), Laparoscopic Cholecystectomy
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients who develop postoperative nausea and/or vomiting within the first 24 hours after laparoscopic cholecystectomy. | |
| 2 | Patients who do not experience postoperative nausea or vomiting within the first 24 hours after laparoscopic cholecystectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between preoperative HRV and postoperative nausea and vomiting (PONV) within 24 hours
Preoperative HRV parameters (SDNN, RMSSD, LF/HF ratio) measured during a 5-min rest using Polar H10/Elite HRV. PONV assessed every 4 hours for 24 hours post-surgery using a 5-point ordinal scale (0-4). The predictive association between HRV and PONV incidence/severity will be evaluated.
Measured: Within 24 hours postoperatively
Secondary outcomes (2)
Preoperative HRV parameters (SDNN, RMSSD, LF/HF ratio).
Preoperative HRV parameters (SDNN, RMSSD, LF/HF) measured during a 5-min rest (Polar H10/Elite HRV). PONV assessed every 4 hours for 24 hours using a 5-point ordinal scale (0-4). Association between HRV and PONV incidence/severity will be evaluated.
Measured: Within 24 hours postoperatively
Postoperative HRV parameters (SDNN, RMSSD, LF/HF ratio).
Postoperative HRV parameters (SDNN [ms], RMSSD [ms], LF/HF ratio) will be measured at the 1st postoperative hour in the PACU using the Polar H10 heart rate sensor and analyzed via the Elite HRV application. These values will be compared to preoperative measurements.
Measured: 1 hour postoperative (PACU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start2 May 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and Vomiting (PONV)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Sami TUTAR, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948708
- Sponsor's protocol ID
- 10.04.2025/ 04-604-02
- Status last verified
- Sep 2025
- First submitted
- 15 Apr 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and data privacy concerns.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Role of Heart Rate Variability in Postoperative Nausea and Vomiting Among Female Patients Undergoing Elective Laparoscopic Cholecystectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06948708
- Acronym / sponsor ID
- 10.04.2025/ 04-604-02
- Conditions
- Postoperative Nausea and Vomiting (PONV), Heart Rate Variability (HRV), Laparoscopic Cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 29 Apr 2025 (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.
Postoperative nausea and vomiting (PONV) are among the most common complications following general anesthesia (GA), significantly affecting patient comfort and recovery. Although various risk factors for PONV have been identified-such as female sex, non-smoking status, and history of motion sickness-these predictors are not always sufficient to determine individual risk accurately.
Heart rate variability (HRV) reflects autonomic nervous system (ANS) balance and has been proposed as a potential physiological biomarker for predicting PONV. Reduced HRV is associated with increased vagal imbalance, which may contribute to gastrointestinal (GI) dysregulation and PONV.
This prospective observational study aims to investigate the predictive value of HRV in estimating the incidence and severity of PONV in female patients undergoing elective laparoscopic cholecystectomy (LC). A total of 110 participants will be enrolled, and preoperative and early postoperative HRV measurements will be obtained using a validated chest-strap heart rate monitor (Polar H10). HRV parameters, including the standard deviation of normal-to-normal intervals (SDNN), the root mean square of successive differences (RMSSD), and the low-frequency/high-frequency (LF/HF) ratio, will be analyzed via the Elite HRV application. Standardized anesthesia, analgesia, and antiemetic protocols will be used for all participants. PONV severity will be assessed over the first 24 hours postoperatively using a 4-point scale.
The primary objective is to evaluate whether preoperative HRV can predict PONV occurrence. Secondary outcomes include correlations between HRV parameters and PONV severity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients who develop postoperative nausea and/or vomiting within the first 24 hours after laparoscopic cholecystectomy. |
| 2 | – | –Patients who do not experience postoperative nausea or vomiting within the first 24 hours after laparoscopic cholecystectomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients aged 18-65 years, scheduled for elective laparoscopic cholecystectomy under general anesthesia at a tertiary care hospital.
Key inclusion criteria (6 listed)
- Female patients aged 18 to 65 years
- Scheduled for elective laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) physical status I
- Body mass index (BMI) < 35 kg/m²
- Non-smokers
Key exclusion criteria (4 listed)
- History of cardiovascular, neurological, or gastrointestinal disease
- Use of medications affecting HRV (e.g., antihypertensives, diuretics, atropine, antidepressants, antipsychotics, steroids)
- Presence of systemic diseases that may affect PONV risk
- Inability to comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between preoperative HRV and postoperative nausea and vomiting (PONV) within 24 hours
Time frame: Within 24 hours postoperatively
Preoperative HRV parameters (SDNN, RMSSD, LF/HF ratio) measured during a 5-min rest using Polar H10/Elite HRV. PONV assessed every 4 hours for 24 hours post-surgery using a 5-point ordinal scale (0-4). The predictive association between HRV and PONV incidence/severity will be evaluated.
2 secondary outcomes
Preoperative HRV parameters (SDNN, RMSSD, LF/HF ratio).
Time frame: Within 24 hours postoperatively
Postoperative HRV parameters (SDNN, RMSSD, LF/HF ratio).
Time frame: 1 hour postoperative (PACU).
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 16 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and data privacy concerns.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (PONV) and Heart Rate Variability (HRV), run by Konya City Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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 16 Sep 2025. 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 Turkey (Türkiye). 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?
Association between preoperative HRV and postoperative nausea and vomiting (PONV) within 24 hours (time frame: Within 24 hours postoperatively). 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 16 Sep 2025.