Predictive Role of HRV for PONV in Laparoscopic Cholecystectomy

NCT ID: NCT06948708

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-02
• Study Completion Date: 2025-09-15

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Patients who develop postoperative nausea and/or vomiting within the first 24 hours after laparoscopic cholecystectomy.

No interventions assigned to this group

2

Patients who do not experience postoperative nausea or vomiting within the first 24 hours after laparoscopic cholecystectomy.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Konya City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mahmut Sami TUTAR

Associate Professor, Department of Anesthesiology and Reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Konya City Hospital

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

10.04.2025/ 04-604-02

Identifier Type: -

Identifier Source: org_study_id