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General Anesthetic

Propofol for Postoperative Nausea and Vomiting (PONV Trial)

Phase 2

Recruiting

Led By Sonal Sharma, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

PONV Trial Summary

This trial aims to determine if giving a low dose of propofol through an IV can help stop patients who usually feel nauseous or vomit after surgery from feeling that way.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Propofol may cause side effects such as drowsiness, mild respiratory issues, headache, or changes in blood pressure. However, since this trial uses a low dose for prevention of PONV, the risk might be lower.

PONV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Nausea (urge to vomit) episodes

Retching (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents) episodes

Vomiting (forceful expulsion of gastric contents) episodes

Secondary outcome measures

Choice of antiemetic- Dexamethasone

Choice of antiemetic- Droperidol

Choice of antiemetic- Ondansetron

+13 more

PONV Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propofol

2017

Completed Phase 4

~1530

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

495 Previous Clinical Trials

2,798,724 Total Patients Enrolled

2 Trials studying Postoperative Nausea and Vomiting

50 Patients Enrolled for Postoperative Nausea and Vomiting

Sonal Sharma, MDPrincipal InvestigatorAssistant Professor, Department of Anesthesiology and Perioperative Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Propofol received approval from the FDA for medical use?

"Our team at Power has appraised the safety of Propofol as a 2 on our scale due to this being a Phase 2 trial, indicating some existing safety data with no evidence supporting its effectiveness."

Answered by AI

What are the main goals being pursued in this research endeavor?

"In this study, the primary aim is to assess episodes of nausea within a 24-hour period. Secondary endpoints encompass the selection and frequency of administration of antiemetic medications such as prochlorperazine and metoclopramide."

Answered by AI

What is the current number of participants involved in this research trial?

"Affirmative. The information available on clinicaltrials.gov indicates an ongoing recruitment drive for this particular trial. Initially listed on February 1st, 2024, the study's most recent update was made on March 26th of the same year. A total of 150 individuals are being sought from a single designated site."

Answered by AI

Are researchers currently enrolling participants for this study?

"Indeed, details on clinicaltrials.gov highlight the ongoing recruitment of subjects for this particular investigation. The trial was initially listed on February 1st, 2024 and last revised on March 26th, 2024. Efforts are being made to enroll a total of 150 participants at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

Sonal Sharma 2024. "Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05759481.

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