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

NCT03432845 | Withdrawn DMC FDA Drug

• 1 other identifier: IRBNet #1187621-1
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• 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.

  Day of surgery

Study Arms (2)

Sugammadex reversal group

Surgical patients will have their muscle relaxant reversed with sugammadex

Other: compare reversal agents

Glycopyrrolate / Neostigmine reversal group

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

Other: compare reversal agents

Interventions

compare reversal agents OTHER

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

Glycopyrrolate / Neostigmine reversal group; Sugammadex reversal group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for planned bariatric surgery

You may qualify if:

• \> 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• WellSpan Health: lead

Related Publications (12)

• Dzwonczyk R, Weaver TE, Puente EG, Bergese SD. Postoperative nausea and vomiting prophylaxis from an economic point of view. Am J Ther. 2012 Jan;19(1):11-5. doi: 10.1097/MJT.0b013e3181e7a512.

  PMID: 20634672 BACKGROUND

• Hambridge K. Assessing the risk of post-operative nausea and vomiting. Nurs Stand. 2013 Jan 2-8;27(18):35-43. doi: 10.7748/ns2013.01.27.18.35.c9486.

  PMID: 23431652 BACKGROUND

• Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18.

  PMID: 24554545 BACKGROUND

• Wengritzky R, Mettho T, Myles PS, Burke J, Kakos A. Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth. 2010 Feb;104(2):158-66. doi: 10.1093/bja/aep370. Epub 2009 Dec 26.

  PMID: 20037151 BACKGROUND

• Gornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, Bost JE, Kluivers KB, Nilsson UG, Tanaka Y, Forbes A. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013 Aug;111(2):161-9. doi: 10.1093/bja/aet014. Epub 2013 Mar 6.

  PMID: 23471753 BACKGROUND

• Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.

  PMID: 22290456 BACKGROUND

• Griffith PS, Birch DW, Sharma AM, Karmali S. Managing complications associated with laparoscopic Roux-en-Y gastric bypass for morbid obesity. Can J Surg. 2012 Oct;55(5):329-36. doi: 10.1503/cjs.002011.

  PMID: 22854113 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• G Power Version 3.0. 10, Faul, F. (2008), Universitat Kiel, Germany

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

Study Officials

• Rich Haas, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 14, 2018
• Study Start: June 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-09