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

September 30, 2019 updated by: Tara L. Moore, WellSpan Health

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

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)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting for planned bariatric surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WellSpan Health

Investigators

  • Principal Investigator: Rich Haas, PhD, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

February 6, 2018

First Submitted That Met QC Criteria

February 12, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IRBNet #1187621-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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