Viewing Study NCT06585540



Ignite Creation Date: 2024-10-26 @ 3:39 PM
Last Modification Date: 2024-10-26 @ 3:39 PM
Study NCT ID: NCT06585540
Status: RECRUITING
Last Update Posted: None
First Post: 2024-09-03

Brief Title: A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population
Sponsor: None
Organization: None

Study Overview

Official Title: A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To assess the effectiveness of Amisulpride to treat Post Operative Nausea and Vomiting PONV and to assess the effectiveness of Amisulpride to prevent PONV following bariatric surgery
Detailed Description: This is a phase IIIIV randomized placebo-controlled patient-blinded cross-over pilot study to evaluate the effectiveness of Amisulpride in the treatment and prevention of Post Operative Nausea and Vomiting PONV in adult patients 18-65 years of age at a single surgery site in the pacific northwest who are undergoing bariatric surgery Approximately 100 patients will be randomized in a 11 ratio to receive a single intravenous dose of Amisulpride 5mg IV single dose or a placebo saline control 1mL IV single dose at the induction of anesthesia Those who initially receive placebo will undergo an additional randomization in the post-anesthesia care unit PACU to receive a dose of Amisulpride 10mg IV single dose or placebo saline control 2mL IV single dose in a 11 ratio as first line treatment for PONV

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None