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Neuromuscular Blockade Agents for Post-Surgery Bowel Recovery

Phase 4

Recruiting

Led By Robert R Field, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age 18 or older

Must not have

No systolic heart failure with reduced ejection fraction (HFrEF)

Incapable of providing consent or understanding the research project

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial compares two drugs to see how they affect time to first bowel movement and tolerance for solid food after colorectal surgery.

Who is the study for?

This trial is for adults over 18 who are having laparoscopic bowel resection surgery and will stay in the hospital afterwards. They must be using specific muscle relaxants during surgery and can't have certain heart, lung or kidney conditions, an ostomy after surgery, or be pregnant. Also, they shouldn't be allergic to the drugs being tested.

What is being tested?

The study compares two drugs used to reverse muscle relaxation from anesthesia: Sugammadex and Neostigmine with Glycopyrrolate. It looks at how quickly patients have their first bowel movement and tolerate solid food after bowel resection surgery.

What are the potential side effects?

Possible side effects of Sugammadex include allergic reactions, changes in heart rate or blood pressure, nausea, pain, headache; while Neostigmine may cause slow heart rate, low blood pressure, saliva increase and intestinal cramps.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having a laparoscopic surgery on my bowel that requires staying in the hospital.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart pumps blood normally.

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I am unable to understand or consent to the research project.

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I have had surgery to remove part of my bowel and now have an ostomy.

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I do not have heart disease shown by a stress test.

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I do not have an autoimmune lung disease.

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I do not have severe lung scarring.

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I do not have COPD that requires me to use home oxygen.

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I do not have lung cancer, either primary or spread from another area.

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I do not have severe heart valve disease.

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I do not have severe high blood pressure in the lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intraoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

GI-2 Recovery

Secondary study objectives

Amount of Fluid Administration

Cost of Stay

Duration of PACU Stay

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Group I: Neostigmine plus GlycopyrrolateActive Control1 Intervention

0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate 2 syringes numbered 1 and 2 1. Syringe #1: Glycopyrrolate 2. Syringe #2: Neostigmine

Group II: SugammadexActive Control1 Intervention

2.0 mg/kg of Sugammadex plus saline equivalent 2 syringes numbered 1 and 2 1. Syringe #1: 0.9% sodium chloride 2. Syringe #2: : full Sugammadex dose + 0.9 sodium chloride (QS to match volume)

0 / 12Eligibility criteria met