Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

Post-operative Nausea and Vomiting Clinical Trial

— PONV  

Official title:

Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759481
• Other study ID #: STUDY00021935
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2024
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: Milton S. Hershey Medical Center
• Contact: Cynthia Reed
• Phone: 7175310003
• Email: creed[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Post-operative Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Propofol
Propofol is administered starting at surgery induction and ending at skin closure

Other:
• Placebo
Placebo is administered starting at surgery induction and ending at skin closure

Locations

Country	Name	City	State
United States	Penn State Health Milton S Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nausea (urge to vomit) episodes	Number of self-reported nausea episodes	24 hours
Primary	Retching (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents) episodes	Number of self-reported retching episodes	24 hours
Primary	Vomiting (forceful expulsion of gastric contents) episodes	Number of self-reported vomiting episodes	24 hours
Secondary	Choice of antiemetic- Dexamethasone	medication administered.	24 hours
Secondary	Number of times dexamethasone administered	frequency of administration	24 hours
Secondary	Choice of antiemetic- Ondansetron	medication administered.	24 hours
Secondary	Number of times ondansetron administered	frequency of administration	24 hours
Secondary	Choice of antiemetic- Promethazine	medication administered	24 hours
Secondary	Number of times promethazine administered	frequency of administration	24 hours
Secondary	Choice of antiemetic- metoclopramide	medication administered	24 hours
Secondary	Number of times metoclopramide administered	frequency of administration	24 hours
Secondary	Choice of antiemetic- Prochlorperazine	medication administered	24 hours
Secondary	Number of times prochlorperazine administered	frequency of administration	24 hours
Secondary	Choice of antiemetic- Droperidol	medication administered	24 hours
Secondary	Number of times droperidol administered	frequency of administration	24 hours
Secondary	Choice of antiemetic- scopolamine	medication administered	24 hours
Secondary	Number of times scopolamine administered	frequency of administration	24 hours
Secondary	Choice of antiemetic-diphenhydramine	medication administered	24 hours
Secondary	Number of times diphenhydramine administered	frequency of administration	24 hours