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临床试验/NCT03276026
NCT03276026终止4 期

A Randomized Prospective Study to Compare the Effectiveness of Neostigmine Versus Sugammadex in Length of PACU Stay in ASA II and III Patients Undergoing Sleeve Gastrectomy Bariatric Surgery

Virtua Health, Inc.1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2018年2月12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
68
试验地点
1
主要终点
Post Anesthesia Care Unit Length of Stay

研究概览

简要总结

The investigators will track bariatric patients who received sugammadex versus neostigmine in the post anesthesia care unit until discharge and assess their length of stay and possible nausea / vomiting / hypoxia episodes.

详细描述

During their preadmission testing, patients planning to undergo sleeve gastrectomy bariatric surgeries will be consented (by having them sign consent forms) and recruited for the study. A trained individual will track these patients after the surgery in the post anesthesia care unit until discharge and assess their length of stay and possible nausea / vomiting. The exact time the investigators are looking to assess is patient arrival to the post anesthesia care unit until patient ready for discharge when the anesthesiologist writes the anesthesia evaluation. The time the reversal agent is administered during the start of skin closure until patient medically ready to leave the post anesthesia care unit will also be taken into account. Blinded to the treatment group, the trained individual will ask each patient every 15 minutes after arrival to the post anesthesia care unit if they are experiencing nausea or vomiting. As an exploratory measure, the trained individual will assess the patient at these same times (every 15 minutes) and determine their oxygen saturation. The investigators will take all the data from the observations and use statistical means to measure what is significant. A discussion and conclusion will follow. Finally, the principal investigator will submit the study outcomes to an anesthesia journal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having sleeve gastrectomy
  • Surgeries performed by a particular surgeon - Dr. Sam Wasser
  • Body Mass Index greater than 35
  • American Society of Anesthesiologists Score II and III patients

排除标准

  • Patients having a different type of bariatric surgery including but not limited to duodenal switch, gastric bypass, hand-assisted laparoscopic sleeve gastrectomy
  • Sleeve gastrectomy's performed by other surgeons than Dr. Sam Wasser.
  • Pregnancy
  • Allergic to sugammadex, Zofran or scopolamine
  • Chronic Obstructive Pulmonary Disease or Asthma that is uncontrolled
  • American Society of Anesthesiologists Score I, IV, V patients

研究组 & 干预措施

Control Group/Neostigmine

Active Comparator

The control group will be the 63 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.

干预措施: Neostigmine (Drug)

Study Group/Sugammadex

Active Comparator

63 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.

干预措施: Sugammadex (Drug)

结局指标

主要结局

Post Anesthesia Care Unit Length of Stay

时间窗: Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).

Determine the difference in length of stay in the post anesthesia care unit from patient arrival until ready for post anesthesia care discharge for the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine in sleeve gastrectomy surgeries.

次要结局

  • Incidence of Postoperative Nausea and Vomiting(Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).)
  • Incidence of Respiratory Complications(Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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