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NCT Number: NCT07386379

Propofol Infusion and PONV in Cardiac Surgery

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yasemin Ozsahin

Istanbul, Outside of the US, 34000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ali Murat Mert

SUB_INVESTIGATOR

Ayla Esin

SUB_INVESTIGATOR

Gozde Altun

SUB_INVESTIGATOR

Kerem Erkalp

CONTACT

[email protected]

+90 532 787 95 00

Yasemin Ozsahin

CONTACT

[email protected]

+90 536 925 67 21

Ziya Salihoglu

SUB_INVESTIGATOR

About this study

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.

Preoperative variables collected for the study will include age, sex, height, weight, body mass index (BMI), ASA physical status classification (ASA PS), smoking status, and history of postoperative nausea and vomiting (PONV) or motion sickness. Intraoperative variables will include type of surgical procedure, anesthesia technique, administered drug doses, PONV prophylaxis, duration of surgery, bypass time, and total anesthesia time.

In the postoperative period, duration of mechanical ventilation in the ICU will be recorded, and nausea/vomiting assessments will be conducted systematically by a blinded observer at 1, 2, 4, 8, and 24 hours after extubation.

Study Timeline Approximately 5-8 CABG procedures are performed weekly at the IUC Cardiology Institute operating suite. Taking into account patients who may be excluded, data collection from approximately 60 patients is expected to be completed within 3 months. An estimated additional 1-month period will be required for data analysis, interpretation, and manuscript preparation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. the effect of high-dose propofol on PONV

    Time frame: 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.

  2. the effect of high-dose propofol on PONV

    Time frame: 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

Secondary outcomes

  1. evaluate the need for antiemetic therapy in ICU

    Time frame: 24 hours

    The secondary objective is to evaluate the need for antiemetic therapy during the intensive care unit stay. Ondansetron requirement (in mg) will be recorded at the 1st, 4th, 8th, and 24th postoperative hours. Routine prophylactic antiemetic therapy will not be administered. Ondansetron will be administered only in patients classified as having moderate or severe nausea and vomiting according to the predefined severity scale, and the administered dose will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Kerem Erkalp

CONTACT

[email protected]

+90 532 787 95 00

Yasemin Ozsahin

CONTACT

[email protected]

+90 536 925 67 21

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Effect of Propofol Infusion on Postoperative Nausea and Vomiting in Cardiac Surgery: A Prospective Observational Cohort Study

Acronym: nausea vomitng

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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