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临床试验/NCT06948708
NCT06948708已完成不适用

The Predictive Role of Heart Rate Variability in Postoperative Nausea and Vomiting Among Female Patients Undergoing Elective Laparoscopic Cholecystectomy: A Prospective Observational Study

Konya City Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
Association between preoperative HRV and postoperative nausea and vomiting (PONV) within 24 hours

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

Association between preoperative HRV and postoperative nausea and vomiting (PONV) within 24 hours

时间窗: Within 24 hours postoperatively

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.

次要结局

  • Preoperative HRV parameters (SDNN, RMSSD, LF/HF ratio).(Within 24 hours postoperatively)
  • Postoperative HRV parameters (SDNN, RMSSD, LF/HF ratio).(1 hour postoperative (PACU).)

研究者

发起方
Konya City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmut Sami TUTAR

Associate Professor, Department of Anesthesiology and Reanimation

Konya City Hospital

研究点 (1)

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