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

68 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to clarify whether or not a low-dose propofol infusion can effectively prevent postoperative nausea and vomiting (PONV) in patients who have a documented history of PONV and/or motion sickness.

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.

What data supports the effectiveness of the drug Propofol for preventing postoperative nausea and vomiting?

Research shows that low doses of Propofol can significantly reduce nausea and vomiting after surgery, with one study reporting an 81% success rate compared to 35% with a placebo. This suggests that Propofol has strong antiemetic (prevents nausea and vomiting) properties. ^{1 2 3 4 5}

Is propofol generally safe for humans?

Propofol is generally safe for humans, but it can cause some side effects like pain on injection, dizziness, and in rare cases, serious reactions like anaphylactic shock (a severe allergic reaction), low blood pressure, and propofol infusion syndrome (a rare but serious condition). It is important to use it with caution and under medical supervision. ^{1 2 6 7 8}

How does the drug propofol help with postoperative nausea and vomiting?

Propofol is unique in treating postoperative nausea and vomiting because it can be used in sub-hypnotic doses (doses that do not cause sleep) to directly reduce nausea and vomiting, unlike traditional antiemetic drugs. It can be administered intravenously and has been shown to be effective even when patients control their own dosage, offering a novel approach compared to standard treatments. ^{2 3 4 5 7}

Research Team

Sonal Sharma, MD

Principal Investigator

Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Low-dose propofol to prevent nausea and vomiting after laparoscopic surgery. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Subhypnotic doses of propofol possess direct antiemetic properties. [2022]

3. India 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Antiemetic activity of propofol after sevoflurane and desflurane anesthesia for outpatient laparoscopic cholecystectomy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Patient-controlled antiemesis: a randomized, double-blind comparison of two doses of propofol versus placebo. [2019]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Vomiting after a pediatric adenotonsillectomy: comparison between propofol induced sevoflurane-nitrous oxide maintained anesthesia and TIVA with propofol-remifentanil. [2021]

7. England 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. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Propofol-associated serious adverse events: an analysis of the FAERS database. [2023]