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Predictive Role of HRV for PONV in Laparoscopic Cholecystectomy

NCT06948708 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2025-09-16

No results posted yet for this study

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.

Conditions

  • Postoperative Nausea and Vomiting (PONV)
  • Heart Rate Variability (HRV)
  • Laparoscopic Cholecystectomy

Sponsors & Collaborators

  • Konya City Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-02
Primary Completion
2025-09-15
Completion
2025-09-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06948708 on ClinicalTrials.gov