Rates and Severity of PONV for Neuromuscular Block Reversal in Patients Receiving Gastric Bypass Bariatric Surgery

Withdrawn

• Conditions: Bariatric Surgery Candidate
• Interventions: Other: compare reversal agents

• Registration Number: NCT03432845
• Lead Sponsor: WellSpan Health

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.

Study Timeline

• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-14
• Study Start: 2018-06-01
• Primary Completion: 2018-12
• Study Completion: 2019-03
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sugammadex reversal group	compare reversal agents	Surgical patients will have their muscle relaxant reversed with sugammadex
Glycopyrrolate / Neostigmine reversal group	compare reversal agents	Surgical patients will have their muscle relaxant reversed with glycopyrrolate and neostigmine

Primary Outcome Measures

Name	Time	Method
PACU PONV rate and severity	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.