Postoperative Nausea and Vomitingnausea vomitngNCT07386379
Propofol Infusion and PONV in Cardiac Surgery
An observational study of Postoperative Nausea and Vomiting and Cardiovascular Surgical Procedures, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting, Cardiovascular Surgical Procedures
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 30 Apr 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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%
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yasemin Ozsahin
Istanbul, Outside of the US, 34000
Yasemin Ozsahin, +90 536 925 67 21, yasemin.ozsahin@iuc.edu.tr
Kerem Erkalp, +90 532 787 95 00, keremerkalp@hotmail.com
About this study
Official title: The Effect of Propofol Infusion on Postoperative Nausea and Vomiting in Cardiac Surgery: A Prospective Observational Cohort Study
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.
Read more
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.
Read the detailed description
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.
- Keywords
- Postoperative Nausea and Vomiting, Propofol, Cardiac Surgical Procedures, Cardiovascular Surgical Procedures
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group H | High-Dose Propofol Group | |
| Group L | Low-Dose Propofol Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 24 hours
Secondary 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Nov 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Ozsahin, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386379
- Sponsor's protocol ID
- 1462022
- Acronym
- nausea vomitng
- Status last verified
- Feb 2026
- First submitted
- 8 Dec 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Propofol Infusion on Postoperative Nausea and Vomiting in Cardiac Surgery: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07386379
- Acronym / sponsor ID
- nausea vomitng / 1462022
- Keywords
- Postoperative Nausea and Vomiting, Propofol, Cardiac Surgical Procedures, Cardiovascular Surgical Procedures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group H | – | –High-Dose Propofol Group |
| Group L | – | –Low-Dose Propofol Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
1 secondary outcome
evaluate the need for antiemetic therapy in ICU
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Nausea and Vomiting and Cardiovascular Surgical Procedures, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasemin Ozsahin (+90 536 925 67 21, yasemin.ozsahin@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of high-dose propofol on PONV (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.