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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
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Choice of antiemetic- Dexamethasone
Choice of antiemetic- Droperidol
Choice of antiemetic- Ondansetron
+13 moreTrial 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
~1520
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Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
510 Previous Clinical Trials
2,796,324 Total Patients Enrolled
Sonal Sharma, MDPrincipal InvestigatorAssistant Professor, Department of Anesthesiology and Perioperative Medicine
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