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NCT06948708
Predictive Role of HRV for PONV in Laparoscopic Cholecystectomy
trial in Postoperative Nausea and Vomiting (PONV) in 110 participants. Completed in 15 September 2025.
15 September 2025
Quick facts
| Lead sponsor | Konya City Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 110 |
| Start date | 2 May 2025 |
| Primary completion | 15 September 2025 |
| Estimated completion | 15 September 2025 |
| Sites | 1 location across Turkey (Türkiye) |
Conditions studied
- Postoperative Nausea and Vomiting (PONV) — all drugs for Postoperative Nausea and Vomiting (PONV) →
- Heart Rate Variability (HRV) — all drugs for Heart Rate Variability (HRV) →
- Laparoscopic Cholecystectomy — all drugs for Laparoscopic Cholecystectomy →
Sponsor
Konya City Hospital
Who can join
Adults 18 to 65, female only, with Postoperative Nausea and Vomiting (PONV) or Heart Rate Variability (HRV). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06948708
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Other Konya City Hospital trials
Trials by the same sponsor.
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- NCT07335250 — Intertransverse Process Block for Postoperative Analgesia After Thoracotomy and Lobectomy · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06948708 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Konya City Hospital
- Last refreshed: 16 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06948708.
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