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Trial record 47 of 185 for:    GLYCOPYRROLATE

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

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ClinicalTrials.gov Identifier: NCT03432845
Recruitment Status : Not yet recruiting
First Posted : February 14, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Rich Haas, 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)

Condition or disease Intervention/treatment
Bariatric Surgery Candidate Other: compare reversal agents

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.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Sugammadex reversal group
Surgical patients will have their muscle relaxant reversed with sugammadex
Other: compare reversal agents
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
Other: compare reversal agents
compare effect of two different approved reversal agents on postoperative and post-discharge nausea and vomiting




Primary Outcome Measures :
  1. PACU PONV rate and severity [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting for planned bariatric surgery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432845


Contacts
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Contact: Rich Haas, PhD 717-851-3326 rhaas@wellspan.org

Sponsors and Collaborators
WellSpan Health
Investigators
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Principal Investigator: Rich Haas, PhD Principal Investigator

Publications:
Smith, C.A., Haas, R.E., Zepp, J.C. and Klein M., 2016. Improving the quality of post-anesthesia care: An evidence based initiative to decrease the incidence of post-operative nausea and vomiting in the post-anesthesia care unit. Perioperative Care and Operating Room Management, 4, pp. 12-16.
Smith C.A., Haas R.E. 2017 Sustaining reductions in postoperative nausea and vomiting after evidence-based practice initiative: A success story. Journal of Health and Social Sciences, 2(2), pp. 149-160.
G Power Version 3.0. 10, Faul, F. (2008), Universitat Kiel, Germany
Lien, CA and Eikermann, M. Neuromuscular Blockers and Reversal Drugs. Pharmacology and Physiology for Anesthesia, Chapter 19, Saunders, Philadelphia. pp. 325-348.
Sheskin, D.J. Handbook of Parametric and Nonparametric Statistical Procedures. CRC Press (1997), Boca Raton.

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Responsible Party: Rich Haas, Principal investigator, WellSpan Health
ClinicalTrials.gov Identifier: NCT03432845     History of Changes
Other Study ID Numbers: IRBNet #1187621-1
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glycopyrrolate
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists