The Effect of Propofol Infusion on Postoperative Nausea and Vomiting in Cardiac Surgery: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the effect of high-dose propofol on PONV
研究概览
简要总结
The aim of this observational cohort study is to evaluate the effect of high-dose versus low-dose propofol infusion on the incidence of postoperative nausea and vomiting (PONV) in patients undergoing coronary artery bypass grafting (CABG). The study also seeks to assess the predictive performance of the Apfel and Koivuranta risk scores for PONV in the cardiac surgery population.
The primary objective of this study is to determine the impact of routinely administered high-dose propofol on the incidence and severity of PONV in CABG patients.
The secondary objective is to evaluate the need for antiemetic therapy during the intensive care unit stay.
The investigators will compare patients receiving high-dose propofol with those receiving low-dose propofol to determine whether the antiemetic effect of propofol is dose-dependent.
Participants will be asked to:
Allow PONV assessments to be performed during the first 24 hours postoperatively,
Provide permission for the collection of clinical data (including demographic characteristics, risk scores, opioid consumption, etc.) for research purposes.
详细描述
This research is designed as a prospective, observational cohort study to be conducted on patients undergoing open-heart surgery between November 2025 and March 2026. In the preoperative period, patients will be instructed to abstain from solid food intake after 24:00 on the night before surgery; consumption of non-alcoholic clear liquids will be allowed until two hours prior to the operation.
All procedures will be performed at the Istanbul University-Cerrahpaşa Cardiology Institute. Following the acquisition of written informed consent, all patients will be transferred to the operating room, where an 18G intravenous cannula will be inserted, and premedication will be administered with midazolam 0.03 mg/kg (IV).
Standard monitoring will include a five-lead electrocardiogram (ECG), heart rate assessment, invasive arterial blood pressure monitoring, and peripheral oxygen saturation measurement. All patients will undergo standard anesthesia induction with midazolam 0.15 mg/kg, fentanyl 10 µg/kg, and rocuronium 0.6 mg/kg (IV). Orotracheal intubation will be performed using an endotracheal tube of appropriate size according to the patient's age and sex.
Following intubation, mechanical ventilation will be initiated and adjusted to maintain an end-tidal carbon dioxide (EtCO₂) level between 35 and 45 mmHg. During anesthesia maintenance, the bispectral index (BIS) value will be kept within the 40-60 range. Total intravenous anesthesia (TIVA) will be maintained using propofol, fentanyl, and rocuronium infusions at the discretion of the attending anesthesiologist.
During surgery, all patients will be connected to a cardiopulmonary bypass (CPB) machine. After completion of graft placement and stabilization of vital signs, patients will be weaned from bypass. Postoperatively, patients will be transported to the intensive care unit (ICU) while still intubated, where mechanical ventilation will be continued and extubation will be performed according to their clinical condition.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •ASA physical status III
- •Elective coronary artery bypass grafting (CABG)
- •Surgery performed at Istanbul University-Cerrahpaşa, Cardiology Institute between November 2025 and March 2026
排除标准
- •Gastrointestinal or central nervous system disorders within the past 3 months
- •Cochlear disorders associated with nausea and vomiting
- •Chronic opioid use
- •Advanced hepatic or renal disease
- •Alcohol or substance abuse
- •Left ventricular ejection fraction < 40%
- •Inability to be weaned from mechanical ventilation within 12 hours postoperatively
- •Postoperative morphine administration in the intensive care unit
- •Combined cardiac procedures (e.g., valve surgery)
- •Off-pump surgery
- •Emergency surgery
- •Reoperation due to bleeding or other complications
- •Refusal to participate
研究组 & 干预措施
Group H
High-Dose Propofol Group
Group L
Low-Dose Propofol Group
结局指标
主要结局
the effect of high-dose propofol on PONV
时间窗: 24 hours
The primary objective of this study is to determine the impact of routinely administered high-dose propofol on the incidence and severity of PONV in CABG patients. Nausea and vomiting will be assessed at the 1st, 4th, 8th, and 24th postoperative hours. The severity will be classified as follows: None: No nausea or vomiting. Mild: Mild nausea or a single episode of vomiting, or nausea triggered by an external stimulus. Moderate: Two episodes of vomiting, nausea occurring without an external stimulus, and the need for one dose of antiemetic medication. Severe: Severe nausea, more than two episodes of vomiting, and the need for multiple doses of antiemetic medication. This follow-up and assessment method was adopted from the following study. Erkalp K, Kalekoglu Erkalp N, Sevdi MS, Korkut AY, Yeter H, Ege SS, Alagol A, Erden V. Gastric Decompression Decreases Postoperative Nausea and Vomiting in ENT Surgery. Int J Otolaryngol. 2014;2014:275860. doi: 10.1155/2014/275860.
次要结局
- evaluate the need for antiemetic therapy in ICU(24 hours)
研究者
Yasemin Ozsahin
specialist
Istanbul University - Cerrahpasa