Clinical trial NCT06948708: Predictive Role of HRV for PONV in Laparoscopic Cholecystectomy
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Nausea and Vomiting (PONV)
Heart Rate Variability (HRV)
Laparoscopic Cholecystectomy
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female patients aged 18-65 years, scheduled for elective laparoscopic cholecystectomy under general anesthesia at a tertiary care hospital.

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.


Eligibility criteria: Inclusion Criteria:

* Female patients aged 18 to 65 years
* Scheduled for elective laparoscopic cholecystectomy
* American Society of Anesthesiologists (ASA) physical status I-II
* 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

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting (PONV) within 24 hours using a 4-point scale.
timeFrame: Within 24 hours postoperatively
Secondary outcomes:
measure: Preoperative HRV parameters (SDNN, RMSSD, LF/HF ratio).
timeFrame: Within 24 hours postoperatively
measure: Postoperative HRV parameters (SDNN, RMSSD, LF/HF ratio).
timeFrame: 1 hour postoperative (PACU).
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
Study officials:
References: