Accessor Blinded Randomized Controlled Study Evaluating the Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Aldrete Score
研究概览
简要总结
In this randomized controlled study, the investigators hypothesize that sugammadex is superior to neostigmine in higher risk patients undergoing laparoscopic outpatient surgery in an urban, stand-alone ambulatory surgery center.
The primary objective of this study is to evaluate the "fit to discharge time in the PACU." The secondary objectives are PACU adverse events, use of additional medications in the PACU, 0-30 day ED or inpatient admissions for a pulmonary diagnosis and patient satisfaction at discharge.
详细描述
There is limited published data in the use of sugammadex for high-risk patient populations, such as those undergoing laparoscopic procedures in standalone outpatient surgery facilities. About 90% of the ambulatory surgical patient population at this institution is non-caucasian with the majority of the higher-risk patients having obesity and one or more additional chronic health conditions. In this randomized controlled study, the investigators hypothesize that sugammadex is superior to neostigmine in higher risk patients undergoing laparoscopic outpatient surgery in an urban, stand-alone ambulatory surgery center.
The primary objective of this study is to evaluate the "fit to discharge time in the PACU." The secondary objectives are PACU adverse events, use of additional medications in the PACU, 0-30 day ED or inpatient admissions for a pulmonary diagnosis and patient satisfaction at discharge.
In this double-blinded randomized controlled study, the study team is evaluating the efficacy and safety of sugammadex in patients undergoing ambulatory surgical procedures. Currently, both neostigmine and sugammadex are standard of care in this institution. Other than the emergent need for NMB reversal, practice preference and individual indications dictate the selection of reversal medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
On the day of surgery, an envelope containing the randomization code will be given to an anesthesiology physician or nurse anesthetist responsible for the clinical care of the study patient. Patients will be randomly allocated to receive neostigmine or sugammadex using a 1:1 allocation ratio. Patients will be stratified based on their ASA physical score. A research associate who is not directly involved with the study procedures will maintain the randomization codes. All others will be blinded
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical score II and III
- •Scheduled for a laparoscopic ambulatory surgery
- •21-60 years of age
- •Able to understand and sign informed consent
排除标准
- •Known allergy to neostigmine or sugammadex
- •Active pulmonary diagnosis
- •American Society of Anesthesia physical score 4 and above
- •Known or suspected neuromuscular disease
- •Documented renal or liver insufficiency (2 fold increase in the labs)
- •Body Mass Index >40
- •Any surgical case brought into the operating room after 4 PM (to avoid any provider bias related to discharging patients before closure of the ambulatory surgery center for the day)
研究组 & 干预措施
neostigmine
Neostigmine is the acetylcholinesterase inhibitor most commonly used in pharmacologically reversing the effects of neuromuscular blockers [8]. Reversal of NMB is facilitated by increasing acetylcholine levels at nicotinic skeletal muscle-binding sites.
干预措施: Neostigmine (Drug)
sugammadex
Sugammadex is a modified gamma-cyclodextrin, the first of a new class of drugs called selective relaxant binding agents, with an unusually high affinity for rocuronium. This medication offers an alternate mechanism of action to antagonize the effects of steroidal neuromuscular blockade agents.
干预措施: Sugammadex (Drug)
结局指标
主要结局
Aldrete Score
时间窗: Up to 5 hours
The Aldrete Score will determine transfer from phase 1 to phase 2 recovery. The following criterias will be scored from 0 to 2- activity level, respiration, blood pressure, consciousness, oxygen saturation. Patients who get a total score of 9 or more are considered ready for discharge from Post Anesthesia Care Unit
Post Anesthetic Discharge Scoring System
时间窗: Up to 5 hours
The Post Anesthetic Discharge Scoring System (PADSS) will be used to determine discharge to home readiness. Six criterias to score- vital signs, ambulation, nausea/vomiting, pain, bleeding and voiding. Each one is given a score from 0 to 2. Patients who get a total score of 9 or more are considered ready for discharge from Post Anesthesia Care Unit
Fit To PACU Discharge
时间窗: Up to 5 hours
Based on Post Anesthetic Discharge Scoring System (PADSS), the primary outcome measure will be calculated as the time from study medication administration to the time of "fit to discharge from Post Anesthesia Care Unit (PACU)."
次要结局
- Rate of adverse events in PACU(Up to 5 hours)
- use of additional medications in PACU(Up to 5 hours)
- Emergency Department or inpatient admissions within 30 days after discharge(30 days after discharge)
- patient satisfaction(Up to 5 hours)
研究者
Curtis Choice
Director, Ambulatory Anesthesia Division
Montefiore Medical Center