Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06112353
Phase
PHASE4
Status
Recruiting
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Conditions

  • Intestinal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neostigmine Injectable Solution — DRUG
    Examine GI-2 recovery
  • Sugammadex injection — DRUG
    Examine GI-2 recovery

Study Details

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

Key Dates

Start date
Apr 17, 2024
Status verified
May 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Neostigmine plus Glycopyrrolate
    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
  • Active Comparator: Sugammadex
    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)

Primary Outcome Measure

GI-2 Recovery [ Time Frame: Up to 24 hours post surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Irvine Medical CenterOrangeCalifornia92868
David Whaley, MS
[email protected]
714.456.5501
Robert R Field, MD (PRINCIPAL_INVESTIGATOR)
Joseph C Carmichael, MD (SUB_INVESTIGATOR)
Steven D Mills, MD (SUB_INVESTIGATOR)
Skandan Shanmugan, MD (SUB_INVESTIGATOR)
Valery C ilchez, MD (SUB_INVESTIGATOR)
Matthew D Whealon, MD (SUB_INVESTIGATOR)
Paulette Mensah, BA (SUB_INVESTIGATOR)

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By research site
UC Irvine Medical Center· Orange, CA

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