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Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

ConditionIntestinal Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About this trial

The purpose of this research study is to see the outcome of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (in hours) to first bowel movement and tolerance for solid food (GI-2 recovery) following bowel resection surgery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Laparoscopic bowel resection surgery under general anesthesia with nondepolarizing neuromuscular blockade with rocuronium or vecuronium, and requiring inpatient admission

Disqualifiers

Allergy to Rocuronium, Vecuronium, or Sugammadex

Bowel resection surgery requiring an ostomy

No severe valvulopathy, no systolic heart failure with reduced ejection fraction (HFrEF), no coronary artery disease with positive stress test for ischemic regional wall motion abnormality

No autoimmune pulmonary disease, no severe pulmonary fibrosis, no severe pulmonary hypertension, no COPD with requirement of home oxygen, no pulmonary cancer of primary or metastatic origin

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neostigmine Injectable Solution

    Drug

    Examine GI-2 recovery

  • Sugammadex injection

    Drug

    Examine GI-2 recovery

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Neostigmine plus GlycopyrrolateActive comparator 1 intervention
Group B: SugammadexActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

GI-2 Recovery

GI-2 recovery as defined as hour to first bowel movement and toleration of oral diet

Time frame
Up to 24 hours post surgery

Secondary outcomes

1

Cost of Stay

Total cost of surgical stay

Time frame
From hospital admission to discharge, up to 30 days
2

Length of Stay

Total time patient is at hospital

Time frame
From hospital admission to discharge, up to 60 days
3

Morbidity & Mortality Rate

Symptomatic disease presence and death

Time frame
30 days post surgery
4

Number of Participants Experiencing Post Reversal Bradycardia

Slowed heart rate following reversal

Time frame
Post surgically but prior to PACU discharge, up to 24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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