Propofol for Postoperative Nausea and Vomiting

(PONV Trial)

Overseen By Ruth Jarbadan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Anti-nausea medications

Disqualifiers: Unable to consent, Allergy to propofol, Emergency surgery

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a low-dose propofol infusion can prevent nausea and vomiting after surgery. It targets individuals who have experienced post-surgical nausea and vomiting or suffer from motion sickness. Participants will receive either the propofol treatment or a placebo, which has no effect. Those planning to undergo surgery under general anesthesia, with a history of these symptoms, and who speak English may qualify. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires that you do not take any anti-nausea medication within 24 hours before surgery. Other medications are not mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that propofol is generally well-tolerated. Studies have found that propofol can reduce the likelihood of postoperative nausea. In one study, only 11.3% of patients who received propofol experienced nausea, a notably low percentage. Another study found that combining propofol with other anesthesia can decrease the need for additional anti-nausea medication after surgery.

These findings suggest that propofol is usually safe. Most patients do not experience serious side effects. However, like any medication, some risks exist. Discussing these risks with a doctor before joining a trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PONV?

Propofol is unique because it's being explored as a low-dose infusion to tackle postoperative nausea and vomiting (PONV), a departure from its usual role as an anesthetic. Most treatments for PONV, like ondansetron or dexamethasone, work by blocking certain brain receptors that trigger nausea. In contrast, propofol may offer a dual benefit by providing mild sedation and antiemetic effects at low doses. Researchers are excited because this could mean fewer side effects and a new way to enhance patient comfort after surgery, potentially offering a faster recovery experience.

What evidence suggests that propofol might be an effective treatment for PONV?

Research shows that propofol can reduce postoperative nausea and vomiting (PONV). Studies have found that using propofol during surgery lowers the need for additional anti-nausea medication. One study revealed that only 5.5% of people felt sick after deep sedation with propofol. Another study found that a small amount of propofol specifically for PONV effectively prevents it. In this trial, participants will receive either a low-dose propofol infusion or a placebo to evaluate its effectiveness in preventing PONV. These findings suggest that propofol might be a good choice for people who often feel sick after surgery. ^{1 3 5 6 7}

Who Is on the Research Team?

Sonal Sharma, MD

Principal Investigator

Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Are You a Good Fit for This Trial?

This trial is for adults at least 18 years old who are having elective surgery under general anesthesia and have a history of postoperative nausea and vomiting (PONV) or motion sickness. Participants must speak English and not have any allergies to propofol.

Inclusion Criteria

No documented allergy/adverse reaction to propofol

English speaking

I have told my doctor about my history of nausea or motion sickness before anesthesia.

Exclusion Criteria

I have taken anti-nausea medication within 24 hours before surgery.

Allergy or adverse reaction to propofol

I cannot give consent on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either low-dose propofol infusion or placebo to prevent postoperative nausea and vomiting

1 day

1 visit (in-person)

Follow-up

Participants are monitored for nausea, vomiting, and the administration of antiemetics for 24 hours post-treatment

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Propofol

Trial Overview The study is testing if a low-dose infusion of propofol can prevent PONV in patients with past experiences of it. Patients will either receive propofol or a placebo, without knowing which one they're getting.

How Is the Trial Designed?

Group I: Propofol Experimental Treatment 1 Intervention

Low-dose propofol infusion at 25 mcg/kg/min

Group II: Placebo Placebo Group 1 Intervention

Same volume of 0.9% normal saline as the study group

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

In a study of 345 parturients undergoing elective cesarean sections, a single sub-hypnotic dose of propofol was found to be as effective as metoclopramide in preventing postoperative nausea and vomiting (PONV).

Propofol significantly reduced the incidence of postoperative pruritus compared to metoclopramide, indicating a potential advantage in managing side effects associated with intrathecal morphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sub-hypnotic dose of propofol as antiemetic prophylaxis attenuates intrathecal morphine-induced postoperative nausea and vomiting, and pruritus in parturient undergoing cesarean section - a randomized control trial. Kampo, S., Afful, AP., Mohammed, S., et al.[2020]

In a study of 90 children undergoing adenotonsillectomy, the incidence of postoperative vomiting (POV) was lower in the group receiving total intravenous anesthesia (TIVA) with propofol-remifentanil (6.7%) compared to the group receiving sevoflurane and nitrous oxide (17.7%), although the overall difference was not statistically significant.

The group using sevoflurane and nitrous oxide experienced a higher frequency of retching in the recovery room, indicating that while both anesthesia methods are safe, TIVA may offer a slight advantage in reducing early postoperative nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vomiting after a pediatric adenotonsillectomy: comparison between propofol induced sevoflurane-nitrous oxide maintained anesthesia and TIVA with propofol-remifentanil. Chung, JH., Kim, YH., Ko, YK., et al.[2021]

In a study of 52 patients experiencing postoperative nausea and vomiting, those treated with a subhypnotic dose of propofol showed an 81% success rate in reducing symptoms, compared to only 35% in the placebo group, indicating its effectiveness as an antiemetic.

Propofol was found to have significant direct antiemetic properties without affecting postoperative pain levels or hemodynamic stability, although a small percentage of patients experienced minor side effects like pain on injection or dizziness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subhypnotic doses of propofol possess direct antiemetic properties. Borgeat, A., Wilder-Smith, OH., Saiah, M., et al.[2022]

In a study of 69 patients, small doses of propofol (20 mg and 40 mg) significantly reduced nausea and vomiting compared to a placebo, with the 20 mg dose being particularly effective and associated with fewer episodes of vomiting and need for rescue antiemetics.

Patients receiving propofol also experienced shorter recovery times in the post-anesthesia care unit (PACU) and reported higher satisfaction with their control of postoperative nausea and vomiting, although there were instances of oversedation in the higher dose group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-controlled antiemesis: a randomized, double-blind comparison of two doses of propofol versus placebo. Gan, TJ., El-Molem, H., Ray, J., et al.[2019]

In a study of 90 women undergoing gynecologic laparoscopic surgery, administering 0.5 mg/kg of propofol significantly reduced the incidence of postoperative nausea and vomiting to 33%, compared to 67% in the placebo group.

No adverse events were reported from the use of propofol, indicating that it is a safe option for preventing nausea and vomiting after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose propofol to prevent nausea and vomiting after laparoscopic surgery. Fujii, Y., Itakura, M.[2016]

A study analyzing 1651 adverse event reports related to propofol from the US FDA database identified 363 significant adverse reaction signals, with anaphylactic shock, hypotension, and propofol infusion syndrome being the most common.

The findings highlight that propofol can cause a wide range of adverse reactions affecting various body systems, indicating that clinicians should exercise caution when using this anesthetic, as many reactions are not listed in the drug's official insert.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propofol-associated serious adverse events: an analysis of the FAERS database. Xuan, G., Zhang, Y., Cui, J., et al.[2023]

In a study of 104 patients undergoing elective lower abdominal surgery, a subhypnotic dose of Propofol (30 mg) was found to be as effective as Metoclopramide (10 mg) in reducing postoperative nausea and vomiting (PONV).

The incidence of PONV was significantly lower in patients receiving Propofol and Metoclopramide compared to those receiving a placebo, indicating that both treatments can effectively manage this common complication after anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of postoperative nausea and vomiting with a subhypnotic dose of Propofol in patients undergoing lower abdominal surgery: A prospective, randomized, double-blind study. Naghibi, K., Kashefi, P., Azarnoush, H., et al.[2020]

In a study of 250 female outpatients undergoing laparoscopic cholecystectomy, administering 0.5 mg/kg of propofol intravenously after sevoflurane anesthesia significantly reduced the incidence of postoperative nausea and vomiting compared to desflurane anesthesia.

Patients receiving propofol had shorter recovery times and lower requests for antiemetic medication, indicating that propofol is effective in enhancing recovery and minimizing nausea after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiemetic activity of propofol after sevoflurane and desflurane anesthesia for outpatient laparoscopic cholecystectomy. Song, D., Whitten, CW., White, PF., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9135299/

Propofol anaesthesia and postoperative nausea and ... Within the 20-60% control event rate, of five patients treated with propofol for maintenance of anaesthesia, one will not vomit or be nauseated in the immediate ...

2. journals.lww.com journals.lww.com/anesthesia-analgesia/fulltext/2024/07000/effect_of_propofol_infusion_on_need_for_rescue.5.aspx

Effect of Propofol Infusion on Need for Rescue Antiemetics... The addition of propofol infusions to volatile-based anesthesia is associated with a dose-dependent reduction in the need for rescue antiemetics in the PACU.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10995605/

Incidence of nausea/vomiting following propofol sedation ... The present study is the first to show that the incidence of nausea and/or vomiting was low (5.5%) after deep sedation with propofol combined with adaptive‐ ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1612322/full

Effect of low-dose ciprofol on postoperative nausea and ... Studies have shown that low-dose propofol (when not used as the primary anesthetic) has a certain anti-nausea and vomiting effect, which can effectively prevent ...

5. asploro.com asploro.com/comparison-of-the-incidence-of-postoperative-nausea-and-vomiting-between-ciprofol-and-propofol-in-patients-undergoing-painless-gastroscopy/

Comparison of the Incidence of Postoperative Nausea and ... Conclusion: Both Ciprofol and Propofol can prevent PONV when used for anaesthesia in patients undergoing painless gastroscopy, with Propofol's ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1875459716300042

The risk of postoperative nausea and vomiting between ... Propofol could decrease the incidence of PONV compared with sevoflurane, although the duration of PONV was not affected as found in previous reports.

7. ashp.org ashp.org/-/media/assets/policy-guidelines/docs/endorsed-documents/endorsed-documents-fourth-consensus-guidelines-postop-nausea-vomiting.pdf

Fourth Consensus Guidelines for the Management of ... This consensus statement presents a comprehensive and evidence-based set of guidelines for the care of postoperative nausea and vomiting ...