Propofol Infusion and PONV in Cardiac Surgery

NCT07386379 | Recruiting DMC

• 1 other identifier: 1462022
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Nausea and Vomiting; Cardiovascular Surgical Procedures

Keywords

Postoperative Nausea and Vomiting; Propofol; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures

Outcome Measures

Primary Outcomes (2)

• 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.

  24 hours

• 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

  24 hours

Secondary Outcomes (1)

• evaluate the need for antiemetic therapy in ICU

  24 hours

Study Arms (2)

Group H

High-Dose Propofol Group

Group L

Low-Dose Propofol Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Yasemin Ozsahin

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

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Central Study Contacts

Yasemin Ozsahin

CONTACT

+90 536 925 67 21; yasemin.ozsahin@iuc.edu.tr

Kerem Erkalp

CONTACT

+90 532 787 95 00; keremerkalp@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: February 4, 2026
• Study Start: November 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)