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Clinical trial

Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

ID
Name
STUDY00021935
Description
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.
Trial arms
Trial start
2024-02-01
Estimated PCD
2026-04-01
Trial end
2026-04-01
Status
Recruiting
Phase
Early phase I
Treatment
Propofol
Propofol is administered starting at surgery induction and ending at skin closure
Arms:
Propofol
Other names:
2,6 di-isopropylphenol
Placebo
Placebo is administered starting at surgery induction and ending at skin closure
Arms:
Placebo
Size
150
Primary endpoint
Nausea (urge to vomit) episodes
24 hours
Retching (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents) episodes
24 hours
Vomiting (forceful expulsion of gastric contents) episodes
24 hours
Eligibility criteria
Inclusion Criteria: 1. Undergoing general anesthesia for elective surgery 2. Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions 3. No documented allergy/adverse reaction to propofol 4. English speaking 5. At least 18 years of age Exclusion Criteria: 1. Any anti-nausea medication taken within 24 hours prior to surgery 2. Unable to provide consent independently 3. Allergy or adverse reaction to propofol 4. Emergency surgery
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-03-28

1 organization

1 product

1 indication

Organization
Milton S. Hershey Medical Center
Product
Propofol
Indication
Post-operative Nausea and Vomiting