Heart Rate Variability (HRV), Laparoscopic Cholecystectomy, Postoperative Nausea and Vomiting (PONV)
Conditions
Brief 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 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.
Interventions
None listed
Sponsors
Konya City Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between preoperative HRV and postoperative nausea and vomiting (PONV) within 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative HRV parameters (SDNN, RMSSD, LF/HF ratio). | Within 24 hours postoperatively | 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. |
| Postoperative HRV parameters (SDNN, RMSSD, LF/HF ratio). | 1 hour postoperative (PACU). | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed