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临床试验/NCT03432845
NCT03432845撤回不适用

Rates and Severity of Postoperative and Post-discharge Nausea and Vomiting of Patients Receiving Sugammadex Versus Neostigmine and Glycopyrrolate for Neuromuscular Block Reversal in Patients Receiving Gastric Bypass Bariatric Surgery

WellSpan Health0 个研究点开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
PACU PONV rate and severity

研究概览

简要总结

Patients who require bariatric surgery frequently bring a panoply of pre-existing comorbidities to the operating theatre. With body mass indices routinely in the 50s and 60s, patients who have bariatric surgery frequently have postoperative and post-discharge nausea and vomiting (PONV and PDNV)

详细描述

There are many causes of post-operative nausea and vomiting in bariatric patients. These include (but are not limited to) the following: 1) mechanical manipulation of the stomach and bowel, 2) post-surgical inflammation of the tissue just operated on, 3) vagal stimulation of the viscera, 4) the administration of volatile anesthetics, 5) the administration of narcotics, 6) the underlying propensity of patient's for post-operative nausea and vomiting, based on prior history, gender, and other factors and 7) the administration of a cholinergic medication for muscle relaxant reversal. From previous work, it is known that alternate techniques are available to mitigate factors two through four, and patient screening has been available to help us determine the likelihood of patients becoming nauseous or vomiting postoperatively (factor #5). However, until the advent of sugammadex, there has been no alternative to factor 6. The use of sugammadex as a reversal agent could dramatically lower the incidence of PONV, while simultaneously providing an excellent level of reversal of neuromuscular blockade. There have been no published studies that have described laparoscopic gastric bypass, sleeve gastrectomy or duodenal switch procedures where complete prevention of PONV has been the result. A secondary objective will be the comparison of pulmonary function before and after surgery between the same two groups. In patients having gastric bypass surgery, not only does PONV aggressively aggravate the tissues which were just surgically manipulated, it also increases the likelihood of decreased ventilatory response, placing patients at risk for aspiration, atelectasis, pneumonia and respiratory failure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • > 18 to <= 70 years of age
  • Severe obesity requiring bariatric surgery
  • Willing and able to give informed consent, or if appropriate, have a legally authorized representative capable of giving consent on the participant's behalf
  • Willing to perform the FVC breathing test
  • Willing to be contacted at home via phone

排除标准

  • • <18 or >=70 years of age
  • No pregnant patients will be enrolled
  • Patients with documented allergies to anesthesia agents or histories of malignant hyperthermia will not be enrolled.
  • Participants must be eligible to receive elective bariatric surgery
  • Participants who are discharged to skilled care facilities rather than home will not be considered for participation
  • Lacking capacity to provide informed consent

结局指标

主要结局

PACU PONV rate and severity

时间窗: Day of surgery

The PONV intensity scale measures occurrence and severity. Scoring: Question 1. Have you vomited or had dry retching? A) NO: 0 points, B) Once or Twice: 2 points, C) Three or more times, 50 points. Question 2. Have you experienced a feeling of nausea? If yes, has your feeling of nausea interfered with ADLs, such as being able to get out of bed, being able to move about freely in bed, being able to walk normally, or eating and drinking? A) No: 0 points, B) Sometimes:1 point, C) Often: 2 points, D) All of the time:25 points. Question 3: Has your nausea been mostly: a) Varying? 1 point, b)Constant? 2 points. Question 4: What was the duration of your feeling of nausea (in hours \[whole or fraction\])? Scoring: Select the highest score of question 1 or 2, then multiply x Q3 x Q4. Minimum 0 points. Maximum score (4 hours) 400 points. Source: Wengritzky R, Mettho T, Myles PS, Burke J, and Kakos A. (2010). BJA, 104 (2), 158-166.

次要结局

未报告次要终点

研究者

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

Tara L. Moore

Principal investigator

WellSpan Health

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