Clinical trial NCT03432845: Rates and Severity of PONV for Neuromuscular Block Reversal in Patients Receiving Gastric Bypass Bariatric Surgery
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bariatric Surgery Candidate
Lead sponsor: WellSpan Health
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for planned bariatric surgery

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* • \> 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

Exclusion Criteria:

* • \<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
  * Prisoner

Primary outcomes:
measure: PACU PONV rate and severity
timeFrame: Day of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Principal Investigator
name: Rich Haas, PhD
role: PRINCIPAL_INVESTIGATOR
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