Propofol Infusion and PONV in Cardiac Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population will consist of adult patients (≥18 years) classified as ASA III who are scheduled to undergo elective coronary artery bypass grafting (CABG) surgery at Istanbul University-Cerrahpaşa Cardiology Institute between November 2025 and March 2026. Patients with recent gastrointestinal or central nervous system disorders, cochlear conditions that may induce nausea or vomiting, chronic opioid use, severe hepatic or renal disease, alcohol or substance abuse, left ventricular ejection fraction \<40%, prolonged postoperative mechanical ventilation (\>12 hours), or postoperative morphine use in the ICU will be excluded. Additional exclusion criteria include combined cardiac procedures (e.g., valve surgery), off-pump CABG, emergency surgery, reoperation due to complications, and refusal to participate.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Group H
Group B: Group L
Trial outcomes
Primary outcomes
1
the effect of high-dose propofol on PONV
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.
Time frame
24 hours2
the effect of high-dose propofol on PONV
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
Time frame
24 hoursSecondary outcomes
1
evaluate the need for antiemetic therapy in ICU
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.
Time frame
24 hoursSponsors and contacts
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Source ClinicalTrials.gov