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

Bariatric Surgery Candidate Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03432845
• Other study ID #: IRBNet #1187621-1
• Status: Withdrawn
• Start date: June 1, 2018
• Est. completion date: March 2019

Study information

• Verified date: September 2019
• Source: WellSpan Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
WellSpan Health

References & 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. — View Citation

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

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. Review. — View Citation

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. Review. — View Citation

Hambridge K. Assessing the risk of post-operative nausea and vomiting. Nurs Stand. 2013 Jan 2-8;27(18):35-43. — View Citation

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

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. — View Citation

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

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.

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.

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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