PONV: Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

Sponsor

Milton S. Hershey Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05759481

Collaborator

(none)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Post-operative Nausea and Vomiting	Drug: Propofol Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Apr 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Propofol Low-dose propofol infusion at 25 mcg/kg/min	Drug: Propofol Propofol is administered starting at surgery induction and ending at skin closure
Placebo Comparator: Placebo Same volume of 0.9% normal saline as the study group	Other: Placebo Placebo is administered starting at surgery induction and ending at skin closure

Arm

Intervention/Treatment

Experimental: Propofol

Low-dose propofol infusion at 25 mcg/kg/min

Drug: Propofol

Propofol is administered starting at surgery induction and ending at skin closure

Placebo Comparator: Placebo

Same volume of 0.9% normal saline as the study group

Other: Placebo

Placebo is administered starting at surgery induction and ending at skin closure

Outcome Measures

Primary Outcome Measures

Nausea (urge to vomit) episodes [24 hours]
Number of self-reported nausea episodes
Retching (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents) episodes [24 hours]
Number of self-reported retching episodes
Vomiting (forceful expulsion of gastric contents) episodes [24 hours]
Number of self-reported vomiting episodes

Secondary Outcome Measures

Choice of antiemetic- Dexamethasone [24 hours]
Number of times dexamethasone administered [24 hours]
Choice of antiemetic- Ondansetron [24 hours]
Number of times ondansetron administered [24 hours]
Choice of antiemetic- Promethazine [24 hours]
Number of times promethazine administered [24 hours]
Choice of antiemetic- metoclopramide [24 hours]
Number of times metoclopramide administered [24 hours]
Choice of antiemetic- Prochlorperazine [24 hours]
Number of times prochlorperazine administered [24 hours]
Choice of antiemetic- Droperidol [24 hours]
Number of times droperidol administered [24 hours]
Choice of antiemetic- scopolamine [24 hours]
Number of times scopolamine administered [24 hours]
Choice of antiemetic-diphenhydramine [24 hours]
Number of times diphenhydramine administered [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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