An observational study in Bariatric Surgery Candidate, sponsored by WellSpan Health. Withdrawn. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-10-03.
Sponsored by WellSpan Health · Observational
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)
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.
WellSpan Health is the lead sponsor of 30 studies on the registry; 7 are open to participants now.
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Patients presenting for planned bariatric surgery
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> 18 to \<= 70 years of age
Exclusion Criteria:
\<18 or >=70 years of age
Surgical patients will have their muscle relaxant reversed with sugammadex
Other: compare reversal agents
Surgical patients will have their muscle relaxant reversed with glycopyrrolate and neostigmine
Other: compare reversal agents
compare effect of two different approved reversal agents on postoperative and post-discharge nausea and vomiting
PACU PONV rate and severity
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.
Time frame: Day of surgery
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This study is withdrawn, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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