Propofol for Postoperative Nausea and Vomiting
(PONV Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
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
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?
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.12678
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.23457
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.
See 2 more
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.
See 1 more
Trial 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 (Other)
- Propofol (General Anesthetic)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PropofolExperimental Treatment1 Intervention
Low-dose propofol infusion at 25 mcg/kg/min
Group II: PlaceboPlacebo Group1 Intervention
Same volume of 0.9% normal saline as the study group
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Penn State Health Milton S Hershey Medical CenterHershey, PA
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Who Is Running the Clinical Trial?
Milton S. Hershey Medical CenterLead Sponsor
References
Low-dose propofol to prevent nausea and vomiting after laparoscopic surgery. [2016]To evaluate the efficacy of administering a low dose of propofol at the end of surgery in preventing postoperative nausea/vomiting in women undergoing gynecologic laparoscopic surgery.
Subhypnotic doses of propofol possess direct antiemetic properties. [2022]Propofol is associated with a low incidence of postoperative nausea and vomiting. In a prospective, randomized, double-blind, placebo-controlled study, we investigated the possible direct antiemetic properties of a subhypnotic dose of propofol. Fifty-two ASA physical status I or II patients, aged 15-60 yr with nausea and vomiting after minor gynecologic, orthopedic, or digestive tract surgery, were included in the study and received either propofol (10 mg = 1 mL) or placebo (1 mL Intralipid) intravenously in the postanesthesia care unit. Patients treated with propofol experienced a larger reduction in nausea and vomiting than patients treated with placebo (81% vs 35% success rate; P less than 0.05). Patients successfully treated had a similar incidence of relapse (propofol 28%; placebo 22%) within the first 30 min after therapy. Thirty-three percent of the propofol-treated patients and 44% of the placebo-treated patients showed a minor increase in sedation. The level of postoperative pain did not change in either group. Hemodynamic values remained unchanged in both groups. Pain on injection (7.6%) or dizziness (3.6%) only occurred in the propofol group. We conclude that propofol has significant direct antiemetic properties.
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]Postoperative nausea and vomiting (PONV) is a common complication after general anesthesia in patients undergoing elective lower abdominal surgery. We aimed to compare the effect of a sub hypnotic dose of Propofol in the prevention of PONV after lower abdominal surgery with that of the conventional antiemetic drug Metoclopramide.
Antiemetic activity of propofol after sevoflurane and desflurane anesthesia for outpatient laparoscopic cholecystectomy. [2019]Controversy exists regarding the effectiveness of propofol to prevent postoperative nausea and vomiting. This prospective, randomized, single-blinded study was designed to evaluate the antiemetic effectiveness of 0.5 mg/kg propofol when administered intravenously after sevoflurane- compared with desflurane-based anesthesia.
Patient-controlled antiemesis: a randomized, double-blind comparison of two doses of propofol versus placebo. [2019]The role of propofol for the management of postoperative nausea and vomiting (PONV) is not well established. This study determines the efficacy of small doses of propofol administered by patient-controlled device for the treatment of PONV.
Vomiting after a pediatric adenotonsillectomy: comparison between propofol induced sevoflurane-nitrous oxide maintained anesthesia and TIVA with propofol-remifentanil. [2021]Anesthesia methods and drugs affect postoperative nausea and vomiting. Propofol is known to have antiemetic effects. We compared the incidence of postoperative vomiting (POV) in children undergoing an adenotonsillectomy; anesthesia in one group was induced with propofol and maintained with sevoflurane and nitrous oxide, and the other group received total intravenous anesthesia (TIVA) with propofol-remifentanil.
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]Postoperative Nausea and Vomiting (PONV) is a dreadful and uncomfortable experience that significantly detracts patients' quality of life after surgery. This study aimed to examine the antiemetic effect of a single sub-hypnotic dose of propofol as prophylaxis for PONV.
Propofol-associated serious adverse events: an analysis of the FAERS database. [2023]Propofol is an ultra-fast-acting intravenous anesthetic, which is rapidly metabolized primarily into inactive compounds in the live and then excreted in the urine. The purpose of this study is to explore the risk signals of propofol based on the US FDA Adverse Event Reporting System database. The risk signals of propofol-related adverse reactions in adverse event (AE) reports from 2004 to 2021 in the US FAERS were mined using ratio-report method (ROR) and the ratio-report ratio method (PRR) methods. We screened out 1651 pairs AE reports using propofol as primary suspect (PS) drugs. ROR, PRR, BCPNN and MGPS methods were used to calculate respectively, there are 363 positive preferred terms (PT) signals with 9549 cases. Among them, the top 3 adverse reactions associated with using propofol from the FAERS database were anaphylactic shock, hypotension and propofol infusion syndrome. The top 3 systems of the body associated with adverse reaction of propofol from the FAERS database were General disorders, Cardiac disorders and administration site conditions and Respiratory, thoracic and mediastinal disorders. The top 4 indication of using propofol from the FAERS database, including anaesthesia, induction of anaesthesia, sedation, general anaesthesia. There are many adverse reactions that are not included in the drug insert of propofol and involve a wide range of organs and/or systems. Caution should be exercised in the clinical use of propofol.