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New treatment option for Bariatric Surgery
Official title Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery
ClinicalTrials.gov ID: NCT07539623
What this study is testing
What is Suzetrigine?
Suzetrigine is an investigational medicine, being studied as a potential treatment for bariatric surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is prospective, randomized study. The purpose of this study is to evaluate whether the addition of Suzetrigine to well established multimodal pain regimen for participants undergoing bariatric patients undergoing weight-loss surgery and cardiac patients undergoing sternotomy will reduce post-operative opioid consumption and pain scores.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Adults 18-85 years old
- Scheduled to undergo cardiac procedures via sternotomy or bariatric surgery (laparoscopic or open)
- All genders
You likely can't join if
- Any individual who meets any of the following criteria will be excluded from participation in this study:
- ASA Class V
- Urgent or emergent surgery
- Contraindications to administration of Suzetrigine (e.g. concomitant use of strong CYP3A inhibitors)
- History of substance use disorder or chronic opioid use
- Reoperation
See the full eligibility criteria
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Adults 18-85 years old
- Scheduled to undergo cardiac procedures via sternotomy or bariatric surgery (laparoscopic or open)
- All genders
- Any individual who meets any of the following criteria will be excluded from participation in this study:
- ASA Class V
- Urgent or emergent surgery
- Contraindications to administration of Suzetrigine (e.g. concomitant use of strong CYP3A inhibitors)
- History of substance use disorder or chronic opioid use
- Reoperation
- Patient refusal or inability to consent
- Patients who take moderate-to-severe CYP3A inhibitors (such as Ritonavir, Voriconazole, and
- Clarithromycin)
- Patients who take moderate-to-severe CYP3A inducers (such as Phenytoin, Carbamazapine, and Rifabutin)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.