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

NCT ID: NCT03432845

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-03-31

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.

Conditions

Bariatric Surgery Candidate

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sugammadex reversal group

Surgical patients will have their muscle relaxant reversed with sugammadex

compare reversal agents

Intervention Type: OTHER

compare effect of two different approved reversal agents on postoperative and post-discharge nausea and vomiting

Glycopyrrolate / Neostigmine reversal group

Surgical patients will have their muscle relaxant reversed with glycopyrrolate and neostigmine

compare reversal agents

Intervention Type: OTHER

compare effect of two different approved reversal agents on postoperative and post-discharge nausea and vomiting

Interventions

compare reversal agents

compare effect of two different approved reversal agents on postoperative and post-discharge nausea and vomiting

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

WellSpan Health

OTHER

Sponsor Role: lead

Responsible Party

Tara L. Moore

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rich Haas, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

Lien, CA and Eikermann, M. Neuromuscular Blockers and Reversal Drugs. Pharmacology and Physiology for Anesthesia, Chapter 19, Saunders, Philadelphia. pp. 325-348.

Reference Type: BACKGROUND

Sheskin, D.J. Handbook of Parametric and Nonparametric Statistical Procedures. CRC Press (1997), Boca Raton.

Reference Type: BACKGROUND

Other Identifiers

IRBNet #1187621-1

Identifier Type: -

Identifier Source: org_study_id