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Набира участници Фаза 3 NCT07539623

Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery

Фаза 3 – широко изпитване преди одобрение
Заболявания: Bariatric Surgery Cardiac Surgery With Sternotomy Post-operative Pain

Спонсор: Icahn School of Medicine at Mount Sinai

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion 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 Exclusion Criteria: 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)
Интервенции
Suzetrigine
DRUG
Placebo
DRUG
Места на провеждане 1
САЩ (1)
Mount Sinai Morningside
New York , New York
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
85 Years
Здрави доброволци
Не
Начална дата
01.04.2026
Крайна дата
22.12.2026
Регистрационен номер
NCT07539623
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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