Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Completed
NCT Number: NCT05759481
Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
About this study
Propofol is administered as both low dose and as sole anesthetic in patients with history of PONV and/or motion sickness. But efficacy of one dose over the other is not studied. This study plans to clarify if propofol in low dose is as effective as its administration as sole anesthetic in patients with history of PONV and/or motion sickness
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Undergoing general anesthesia for elective surgery
- Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions
- No documented allergy/adverse reaction to propofol
- English speaking
- At least 18 years of age
Exclusion criteria
- Any anti-nausea medication taken within 24 hours prior to surgery
- Unable to provide consent independently
- Allergy or adverse reaction to propofol
- Emergency surgery
Treatment and study plan
Propofol
DrugPropofol is administered starting at surgery induction and ending at skin closure
Other names: 2,6 di-isopropylphenol
Placebo
OtherPlacebo is administered starting at surgery induction and ending at skin closure
Primary outcomes
-
Nausea (urge to vomit) episodes
Time frame: 24 hours
Number of self-reported nausea episodes
-
Retching (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents) episodes
Time frame: 24 hours
Number of self-reported retching episodes
-
Vomiting (forceful expulsion of gastric contents) episodes
Time frame: 24 hours
Number of self-reported vomiting episodes
Secondary outcomes
-
Choice of antiemetic- Dexamethasone
Time frame: 24 hours
medication administered.
-
Number of times dexamethasone administered
Time frame: 24 hours
frequency of administration
-
Choice of antiemetic- Ondansetron
Time frame: 24 hours
medication administered.
-
Number of times ondansetron administered
Time frame: 24 hours
frequency of administration
-
Choice of antiemetic- Promethazine
Time frame: 24 hours
medication administered
-
Number of times promethazine administered
Time frame: 24 hours
frequency of administration
-
Choice of antiemetic- metoclopramide
Time frame: 24 hours
medication administered
-
Number of times metoclopramide administered
Time frame: 24 hours
frequency of administration
-
Choice of antiemetic- Prochlorperazine
Time frame: 24 hours
medication administered
-
Number of times prochlorperazine administered
Time frame: 24 hours
frequency of administration
-
Choice of antiemetic- Droperidol
Time frame: 24 hours
medication administered
-
Number of times droperidol administered
Time frame: 24 hours
frequency of administration
-
Choice of antiemetic- scopolamine
Time frame: 24 hours
medication administered
-
Number of times scopolamine administered
Time frame: 24 hours
frequency of administration
-
Choice of antiemetic-diphenhydramine
Time frame: 24 hours
medication administered
-
Number of times diphenhydramine administered
Time frame: 24 hours
frequency of administration
Sponsors and collaborators
Lead sponsor
Milton S. Hershey Medical Center
Other
Registry information
Acronym: PONV
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Mar 8, 2023
- Registry last updated
- Apr 2, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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