Predictive Role of HRV for PONV in Laparoscopic Cholecystectomy

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.

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 Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy; Postoperative Nausea and Vomiting (PONV); Heart Rate Variability (HRV)

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Konya, Turkey (Türkiye), 42090
    • Konya City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour postoperative (PACU).
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.	Within 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2025
• Primary Completion (Actual): September 15, 2025
• Study Completion (Actual): September 15, 2025

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 10.04.2025/ 04-604-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to institutional policies and data privacy concerns.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No