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临床试验/NCT05256901
NCT05256901终止4 期

Effectiveness of Sugammadex Versus Neostigmine on Neuromuscular Reversal in Pediatric Patients Undergoing Laparoscopic Appendectomy for Acute Appendicitis: A Randomized Controlled Trial

Emory University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年7月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
22
试验地点
1
主要终点
Total Time From Surgery End to Out of the Operating Room (OR)

研究概览

简要总结

This study is designed as a randomized controlled trial with patients assigned to neuromuscular reversal with either sugammadex or neostigmine/glycopyrrolate reversal. The study will not be blinded to the anesthesiologist to allow for appropriate decision-making on timing and dosage of reversal. This is a single-center study.

详细描述

Patients presenting to the operating room for laparoscopic appendectomy with a diagnosis of acute appendicitis require rapid sequence induction (RSI) due to significant vomiting and concern for increased gastric content. For this reason, succinylcholine-accompanied by neostigmine-is predominantly used in adults for RSI to prevent potential aspiration. Unfortunately, in pediatric patients, there are many concerns about the use of succinylcholine, including complications such as bradycardia, hyperkalemia, dysrhythmias, and cardiac arrest from undiagnosed skeletal muscle myopathy. For many anesthesiologists, these concerns prompted the decision to use a non-depolarizing muscle relaxant such as rocuronium for induction. However, if the standard RSI dose is used, it often results in residual paralysis at the end of short procedures such as laparoscopic appendectomies. It has recently been demonstrated that prolonged paralysis is prevalent even at low doses of rocuronium in pediatric patients. For these reasons, it is imperative to find a way to provide adequate and safe

RSI conditions for intubation, appropriate muscle relaxation for laparoscopic procedures, and the ability to quickly reverse neuromuscular blockade in this pediatric population. Sugammadex has the potential to allow for the utilization of an appropriate RSI dose of rocuronium for intubation, as it provides the ability to reverse neuromuscular blockade earlier than the neostigmine reversal, which is currently the standard of care. Retrospective reviews have shown the use of Sugammadex in pediatric patients to be safe and effective. However, there has not been prospective data about the effect on operating room efficiency of brief pediatric procedures such as laparoscopic appendectomies, one of the most common urgent pediatric surgeries performed. There are numerous other potential benefits of using sugammadex over typical reversal, including the quicker return of bowel function, faster time to tolerance of an oral diet, and decreased exposure to volatile anesthesia. The return of bowel function is particularly important in pediatric patients undergoing laparoscopic procedures. The research team hypothesizes that the utilization of sugammadex in pediatrics results in a quicker return to bowel function. This has previously been demonstrated in adults, but data are lacking in the pediatric population. Researchers also hypothesize that patients receiving sugammadex versus neostigmine reversal will have an improved time to tolerance of an oral diet, which may impact wound healing and nutrition. As anesthesiologists often underdose rocuronium in these short procedures, due to a lack of quick reversal options, high levels of volatile anesthesia are utilized to compensate for inadequate muscle relaxation. With the use of sugammadex allowing for proper muscle relaxation throughout the entire case, researchers hypothesize that patients will have a lower total volatile anesthetic exposure during the procedure. This is exceedingly important in pediatric anesthesia, where the detrimental effects of volatile anesthetics on the developing brain have been demonstrated in numerous animal studies.

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
Single (Participant)

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients 2-17 years of age
  • Diagnosis of acute appendicitis
  • Patient undergoing laparoscopic appendectomy at Children's Healthcare of Atlanta- Egleston.
  • Parent or Legal Authorized Representative willing to participate, able to understand and sign an informed consent

排除标准

  • Patient with an allergy to Sugammadex or Neostigmine
  • History of renal dysfunction
  • Parent or legal guardian unwilling or unable or unable to understand the informed consent

研究组 & 干预措施

Sugammadex

Experimental

The reversal agent, Sugammadex, will be administered at the start of closure.

干预措施: Sugammadex (Drug)

Neostigmine/Glycopyrrolate

Active Comparator

The reversal agent, Neostigmine, will be administered at the start of closure.

干预措施: Neostigmine/Glycopyrrolate (Drug)

结局指标

主要结局

Total Time From Surgery End to Out of the Operating Room (OR)

时间窗: Up to 2 hours

The time from the end of surgery to discharge from the OR will be evaluated via the Epic computer chart after discharge from the hospital.

次要结局

  • Total Time of Inhalational Anesthesia Exposure(Up to 5 hours (depending on length of surgical procedure))
  • Total Time to First Bowel Movement(Up to 48 hours)
  • Total Time to Tolerance of an Oral Diet(Up to 24 hours)
  • Length of Stay in the Post-anesthesia Care Unit (PACU)(Up to 5 hours (on average depending on post anesthesia recovery))
  • Hospital Length of Stay (LoS)(Up to 5 days (depending on length of hospitalization))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Gilbertson

Assistant Professor

Emory University

研究点 (1)

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