Predictive Role of HRV for PONV in Laparoscopic Cholecystectomy

NCT06948708 | Completed

• 1 other identifier: 10.04.2025/ 04-604-02
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Preoperative HRV parameters (SDNN, RMSSD, LF/HF ratio).

  Within 24 hours postoperatively

• Postoperative HRV parameters (SDNN, RMSSD, LF/HF ratio).

  1 hour postoperative (PACU).

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 29, 2025
• Study Start: May 2, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)