Preoperative Use of Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting (PONV) in Patients With History of Severe PONV - Open Label, Prospective, Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
研究概览
简要总结
The objective of the study is to evaluate the efficacy and safety of adding transdermal preparation of granisetron (Sancuso ®) to the current postoperative nausea and vomiting (PONV) standard prophylaxis regimen with dexamethasone and ondansetron in patients with the previous history of severe, particularly delayed and/or post-discharge, PONV and undergoing surgical procedure under general anesthesia.
The specific aims of the study include:
- efficacy of the investigated therapy in prevention of PONV up to 120 hours after surgery
- incidence and seriousness of the observed side effects
- ability of patients to self-administer preoperatively and maintain the investigated patch during the perioperative period
- level of satisfaction with the preoperative PONV prophylaxis.
详细描述
Patients will be recruited from the surgical population undergoing preoperative evaluation in Anesthesiology Preoperative Evaluation Clinic at Hershey Med. Ctr. (~15,000 per year). Selected patients (ASA 1-3, N=60) with history of severe PONV after one or more of previous general anesthesia, and scheduled to undergo surgical procedures with general anesthesia will be enrolled into IRB approved protocol. The patch will be placed by the patient at home 24 - 48 hours before surgery as directed by the doctor. The subsequent standardized general anesthesia protocol for elective surgery will include general endotracheal anesthesia with sevofluran, including standard intraoperative PONV prophylaxis (IV dexamethasone and IV ondansetron, each 4 mg). Postoperative evaluation will include recording of incidence and severity of PONV at the time of discharge from PACU (acute PONV), at 24 hr, 48 hrs, 72 and 120 hrs (delayed or post discharge PONV).
7.2.1 Visit 1 - Anesthesia Preoperative Evaluation Clinic and recruitment and drug dispensation Patient is seen in clinic and identified as having a history of serious PONV, in particular delayed or post discharge PONV. Study will be explained to the patient and consent obtained. The investigational pharmacy will be notified that a study patient has been enrolled and they will prepare the patches for distribution to the patient.
A member of the research team will obtain the assigned patches from the investigational pharmacy and deliver to the anesthesia provider (member of the research team).
The provider will then demonstrate to the patient how to apply the patch and the patient can practice using a placebo patch to show that the correct placement. Patient will then take the actual patch home with them.
7.2.2 Visit 2 - approximately 24-48 hours preoperatively (patient's home) Patient will apply the patch to their upper arm 24-48 hours before scheduled surgical procedure, as instructed during their pre-op anesthesia visit. The patch will then remain in place until 120 hours after surgical procedure. No backup patch will be provided so the patients with the accidently missing patch will need to call their primary surgical service for the standard antiemetic medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that are between the ages of 18 and 89
- •Scheduled to undergo surgical procedures with general anesthesia
- •Seen in the anesthesia clinic at least 24 hours before surgery
- •History of severe PONV after previous general anesthesia
- •Surgical procedures with anticipated duration > 1 hour and no more than 5 hours
- •American Society of Anesthesiologists (ASA) physical status I to III
排除标准
- •Allergy to granisetron or other 5HT3RA drugs
- •Previous allergic reactions to any drug skin patches
- •Recent (less than 1 month) or current chemo- or radiotherapy
- •Any nausea, vomiting, or retching within 24 hours prior to anesthesia
- •Any type of eye surgeries
- •History or diagnosis of gastrointestinal obstruction or ileus
- •History of serotonin syndrome
- •Unable to sign consent
研究组 & 干预措施
Admnistration of granisetron
Preoperative administration of granisetron transdemal patch
干预措施: granisetron (Drug)
结局指标
主要结局
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
时间窗: 24 hrs, 48 hrs, 72 hrs and 120 hrs
Composite measure consisting of complete response (CR), defined as no emetic episode and no rescue medication; the proportions of patients with no emesis and no additional rescue medication in the 120 hours following the completion of surgical procedure.
次要结局
未报告次要终点
研究者
Piotr K Janicki MD, PhD
Professor of Anesthesiology
Milton S. Hershey Medical Center