A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants With "Complete Response" in the Post Anesthesia Care Unit
研究概览
简要总结
The purpose of this study is to evaluate the drug, Barhemsys (Amisulpride), on Postoperative Nausea and Vomiting following Bariatric surgery. Postoperative nausea and vomiting is any nausea or vomiting that occurs within 24 hours following surgery.
Barhemsys is approved for the treatment and prevention of Postoperative Nausea and Vomiting in the United States by the U.S. Food and Drug Administration (FDA).
You are being asked to take part in this study because you are going to receive anesthesia and nausea medication for your bariatric surgery. General anesthesia is used to put a person in a deep sleep, so they do not feel pain during surgery.
If you choose not to participate in the study, you and your doctor will discuss which nausea medications will be provided to you under general anesthesia. If you do participate in the study, you will be randomly assigned (like flipping a coin) into one of two groups, but you won't be told which group you are in:
- Group A will receive anesthesia and nausea medications that include dexamethasone, ondansetron, propofol and the study drug, Barhemsys
- Group B will receive anesthesia and nausea medications that include dexamethasone, ondansetron, and propofol. Group B patients will not receive Barhemsys during anesthesia. Instead, Group B will receive a placebo. A placebo is a substance that is made to look like a drug but has no drug in it. This is so that no one knows you are in Group B.
If you have Nausea after your surgery and you are in Group B, you may receive Barhemsys as a treatment or an additional placebo treatment. Half of group B is expected to receive Barhemsys and half will receive Placebo. If you continue to have nausea you will be provided additional medication to treat your symptoms. You will not be denied medications that are part of the standard of care for treating nausea following surgery.
If you participate in this study, researchers will:
Evaluate your medical history to make sure you are eligible to participate. Randomly assign you to either the group receiving anesthesia with Barhemsys or to the group receiving anesthesia without Barhemsys Collect information about your health before, during and after your bariatric surgery.
Collect information about your nausea and the nausea medications you are prescribed as part of your normal care after your surgery.
Your direct participation is expected to last for 24 hours after your surgery. Researchers may continue to access your medical records to follow how you are doing and audit data.
Risks:
All general anesthetics have some risk of reaction to medications given. Barhemsys is part of a class of medications that can cause chills, low potassium, low blood pressure or abdominal distension.
Patients in the placebo group may experience more nausea. There is a risk of loss of confidentiality of your information. You will read about the steps we take to help keep your information private and secure later in this form.
If you agree to take part in this study, and receive the study drug, Barhemsys, there may be a direct benefit to you as the study drug may be more effective at treating post surgery nausea and vomiting following bariatric surgery. We hope the information learned from this study will benefit other people who undergo Bariatric Surgery in the future.
Taking part in this study is voluntary, and you may choose not to take part or may leave the study at any time. Choosing not to take part or leaving the study will not result in any penalty or loss of benefits to which you are entitled outside of this research.
详细描述
Nausea and vomiting are two of the most common adverse events following general anesthesia with an incidence of 30% in the general population and 80% in high-risk individuals1. In the bariatric surgical population PONV has been reported to affect nearly 80% of this surgical population, with one study showing nearly 60% PONV rates despite adequate prophylaxis. Postoperative Nausea and Vomiting (PONV) is a large patient dissatisfier and contributes to increased post-anesthesia care unit (PACU) length of stay, unanticipated hospital admissions, and increased healthcare costs. Research has shown that 30% of high-risk individuals will experience PONV despite adequate prophylaxis. Current PONV research endorses providing multiple antiemetics that have mechanisms of action at multiple separate receptors to reduce the risk of PONV.
Prevention of Post-operative nausea and vomiting is particularly important in high-risk surgeries when PONV can be associated with significant morbidity. Bariatric surgery is one instance where retching or emesis in the immediate postoperative period can have detrimental effects on the surgical anastomosis. Current literature supports the use of Barhemsys to prevent and treat PONV in the general surgical population6, however, the use of Barhemsys in high-risk bariatric surgeries is a major area lacking in research and evidence-based treatment. Barhemsys is the only FDA approved drug approved for the treatment and prevention of PONV.
The goal of this study is to assess the effectiveness of Barhemsys as a PONV preventative in a high-risk surgical population at distinct timepoints-first during induction of anesthesia, second following bariatric surgery, as measured by subject reported nausea or vomiting, or use of rescue antiemetics during PACU stay and within 24 hours following their surgical procedure, overall subject satisfaction, and PACU length of stay.
Prospective, randomized, subject blinded, placebo-controlled crossover pilot study.
Primary Arm: This pilot study will utilize a randomized, subject-blind, placebo-controlled crossover trial design to evaluate the efficacy of Barhemsys in preventing PONV in bariatric surgery patients at a single surgery site, Virginia Mason Medical Center. Anesthesia providers (Certified Registered Nurse Anesthetists, Physicians) will not be blinded due to subject care, nausea control is the most effective when you use drugs from different classes, not knowing the drug previously provided to subjects will prevent optimal nausea control and prevention. Research staff, performing subject observations, and subjects will be blinded to the study medications. Subject pre-screening will include a review of the subject's health history and current medications. Those subjects meeting criteria and consenting to participate, will be randomized in a 1:1 fashion to one of two groups with a computer-generated arm assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study will recruit adult patients (Age 18-65) scheduled for bariatric surgery. Additional inclusion criteria include ASA class I-III and patients who plan to be inpatient for at least 24 hours.
- •Included Surgeries:
- •Robotic, Laparoscopic or Open Roux-en-Y Robotic, Laparoscopic or Open Gastric Sleeve Robotic, Laparoscopic or Open Gastrectomy Robotic, Laparoscopic or Open Revision Gastric Bypass
排除标准
- •Pregnant or breastfeeding
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •Congenital QTc abnormalities
- •Current use of droperidol
- •Parkinson's disease
- •Allergy to Barhemsys
- •GFR < 30 mL/min/1.73m2
- •Emergency surgery or add-on cases
研究组 & 干预措施
Group Barhemsys
Interventional arm receiving Barhemsys during surgery
干预措施: Amisulpride IV Prevention (Drug)
Group Placebo
Placebo arm receiving Placebo during surgery
干预措施: Placebo Preventative (Drug)
Group Placebo Barhemsys
Of patients who are members of Group Placebo they will be able to receive Barhemsys in the Post Anesthesia Care Unit if they experience nausea or emesis
干预措施: Amisulpride IV Treatment (Drug)
Group Placebo Placebo
Of patients who are members of Group Placebo they will be able to receive Placebo in the Post Anesthesia Care Unit if they experience nausea or emesis
干预措施: Placebo Treatment (Drug)
结局指标
主要结局
Number of Participants With "Complete Response" in the Post Anesthesia Care Unit
时间窗: Until Patient Leaves Post Anesthesia Care Unit (60-120 minutes)
Complete response is defined as no occurrence of vomiting or retching, no nausea score ≥ 1 and no use of rescue medication during their Post Anesthesia Care Unit stay.
次要结局
- Incidence of complete response to established Post-operative Nausea and Vomiting(Until Patient leave Post Anesthesia Care Unit (60-90 minutes))
- Number of participants with no nausea(Up to 24 hours following surgery)
- Number of Participants with no Emesis(Up to 24 hours following surgery)
- Number of Participants With no Use of Rescue Medication(Up to 24 hours following surgery)
- The Number of Participants With no Emesis, no Significant Nausea, and no Use of Rescue Medication(Up to 24 hours following surgery)
- The Number of Participants With no Significant Nausea(Up to 24 hours following surgery)
研究者
Justin Liberman
Staff Anesthesiologist, Department of Anesthesia
Benaroya Research Institute