The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Time to GI-2 bowel function after surgery
研究概览
简要总结
The aim of the study is to determine if the usage of sugammadex would reduce the time to return of bowel function when compared to standard of care (neostigmine/glycopyrrolate) when used for neuromuscular blockade reversal in patients with open abdominal wall reconstruction (AWR).
详细描述
The investigators baseline postoperative ileus (POI) rate in the setting of open abdominal wall reconstruction (AWR) is similar to patients undergoing an open bowel resection and often prolongs patients' hospital stay. Therefore, the investigators aim to determine whether the use of sugammadex has a clinically significant impact on return of postoperative bowel function and prevention of POI in these patients.
The primary outcome is GI-2: postoperative time until passage of 1st bowel movement and tolerance of solid food.
The investigators hypothesize:
- postoperative time to return of bowel function (GI-2) after open AWR will be significantly shorter for patients who receive sugammadex for reversal of neuromuscular blockade when compared to those receiving standard of care (neostigmine/glycopyrrolate).
- patients who receive sugammadex for reversal of neuromuscular blockade will have a reduced incidence of POI requiring nasogastric tube (NG) placement, and decreased length of hospital stay when compared to standard of care.
Specific Aim 1: To determine if the use of sugammadex for neuromuscular blockade reversal reduces the time to postoperative GI-2 bowel function compared to neostigmine/glycopyrrolate for neuromuscular blockade reversal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The patient will be blinded as to what medication they receive for reversal of neuromuscular blockade
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >18 years old
- •Patients requiring an open ventral hernia repair with retromuscular mesh placement and at least one myofascial advancement flap
- •Hernias with fascial defects < 20cm wide
- •Non-emergent cases
排除标准
- •Known serious or severe hypersensitivity reaction to sugammadex or any of the ingredients in sugammadex.
- •Hernias with fascial defects > 20cm wide
- •Concomitant treatment with a strong or moderate cytochrome P450 3A4 inhibitor (e.g., Ketoconazole and other anti-fungals, Clarithromycin, HIV protease inhibitors, diltiazem, erythromycin, verapamil) or strong CYP3A4 inducers (e.g., rifampin).
- •Known small bowel obstruction (SBO) at the time of hernia repair
- •Suspected SBO or at risk of recurrent SBO at the time of hernia repair - at the discretion of the staff surgeon.
- •Nasogastric (NG), orogastric (OG), or gastric (eg. PEG) in place at the time of hernia repair and left in beyond the morning of the first postoperative day.
- •Patients with a stoma.
- •Cancer with increased risk of gastro-duodenal perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab) - at the discretion of the staff surgeon.
- •Disorder that could alter the integrity of the gastrointestinal lining (e.g., Crohn's disease) - at the discretion of the staff surgeon.
- •Severe hepatic failure (Child-Pugh Class C).
- •Clinically relevant hepatic failure (e.g. cirrhosis) - at the discretion of the staff surgeon.
- •Severe renal failure (GFR<30ml/min, on dialysis, or have an arteriovenous fistula, indwelling hemodialysis catheter or peritoneal dialysis catheter) - at the discretion of the staff surgeon.
- •Pregnant or planning to become pregnant during study period.
- •Breastfeeding or planning to breastfeed during study period.
- •Clinically relevant alteration of the blood-brain-barrier - at the discretion of the staff surgeon.
- •Other contraindication to sugammadex as documented by a physician.
- •Unable to give informed consent; vulnerable populations; non-English speaking.
- •Emergent operation.
- •Undergoing minimally invasive approaches.
- •Undergoing repair with mesh placed in a position other than retromuscular.
- •Chronic opioid users, as defined by the daily use of opioids for at least 90 days within the past year
- •Inability to safely extubate the patient at the end of the surgery for any reason, as determined by the operative team.
研究组 & 干预措施
Neostigmine/Glycopyrrolate
Patients assigned to the control arm receive the standardized reversal neostigmine dose with on-label dosing (0.03-0.07mg/kg) and a fixed ratio of glycopyrrolate
干预措施: Neostigmine / Glycopyrrolate (Drug)
Sugammadex
Patients randomized to the experimental arm will receive an IV dose of sugammadex according to the package insert of 2 mg/kg for ≥ 2 twitches, 4 mg/kg for 1-2 post-tetanic twitches
干预措施: Sugammadex (Drug)
结局指标
主要结局
Time to GI-2 bowel function after surgery
时间窗: From time of randomization to progression of bowel function, which is an average of 87 hours, or until 1 month after randomization; whichever comes first
The median time to first postoperative bowel movement and tolerance of solid food (defined as GastroIntestinal-2), as measured in hours, will be recorded for each patient and compared between the two groups.
次要结局
- Length of stay(From time of randomization to progression allowing safe discharge home, which is an average of 6 days, or until 1 month after randomization; whichever comes first)
- Postoperative nasogastric tube placement rate(Up to 1 month after randomization)
- Postoperative complications(Up to 1 month after randomization)
- Postoperative pain(Postop day 1, 2, 3, and 4)
- Opioid used in morphine milligram equivalents(Postop day 1, 2, 3, and 4)
研究者
Clayton Petro
Assistant Professor of Surgery Lerner College of Medicine
The Cleveland Clinic