Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Pharmacy will randomly assign participants. All pills will be made to look identical prior to supplying to participants, investigators, assessors.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Bariatric Placebo
Participants undergoing bariatric surgery will receive 2 pills of a placebo pill made to look like Suzetrigine capsule pre-operatively and 1 pill every 12 hours after for a total of 5 days.
干预措施: Placebo (Drug)
Cardiac Placebo
Participants undergoing cardiac surgery with sternotomy will receive 2 pills made to look like Suzetrigine capsule pre-operatively and 1 pill every 12 hours after for a total of 5 days.
干预措施: Placebo (Drug)
Bariatric Suzetrigine
Participants undergoing bariatric surgery will receive 100 mg loading dose (2 pills) of Suzetrigine pre-operatively and 50 mg dose (1 pill) every 12 hours after for a total of 5 days.
干预措施: Suzetrigine (Drug)
Cardiac Suzetrigine
Participants undergoing cardiac surgery with sternotomy will receive 100 mg loading dose (2 pills) of Suzetrigine pre-operatively and 50 mg dose (1 pill) every 12 hours after for a total of 5 days.
干预措施: Suzetrigine (Drug)
结局指标
主要结局
Opioid Consumption
时间窗: 5 days
Total post-operative opioid consumption measured daily in total morphine milligram equivalents.
次要结局
- Pain Visual Analog scores(5 days)
研究者
Himani Bhatt-Verma
Associate Professor
Icahn School of Medicine at Mount Sinai