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Phase 4 Completed N=120 Randomized Triple-blind Prevention

Sugammadex To IMprove Bowel Function

Bowel Dysfunction · Postoperative Complications · Neuromuscular Blockade
Source: ClinicalTrials.gov NCT04546672 ↗
Enrolled (actual)
120
Serious AEs
5.8%
Results posted
Jul 2024
Primary outcomePrimary: Gastric Emptying — 1120; 1130 log(ng*ml-1)*min — p=0.58
◆ Published Evidence
Emerging
3citations · ~3 / year
A Randomized Controlled Trial of Sugammadex versus Neostigmine for Reversal of Rocuronium on Gastric Emptying in Adults Undergoing Elective Colorectal Surgery.
Anesthesia and analgesia · 2025 · Likely link

Summary

Colon and rectal surgery is associated with high cost, long length of stay, high postoperative surgical site infection rate, high incidence of postoperative nausea and vomiting, and a high rate of hospital readmission. Return of bowel function is of utmost importance in avoiding patient discomfort, morbidity, and mortality after colorectal surgery. All patient having colorectal surgery receive neuromuscular paralysis, which is reversed at the end of surgery with either glycopyrrolate and neostigmine, or sugammadex. Glycopyrrolate and neostigmine both affect bowel function. Sugammadex has no effect on bowel function. The purpose of this study is to determine if a strategy of neuromuscular reversal with sugammadex, instead of glycopyrrolate and neostigmine, may increase gastric emptying after surgery and lead to less postoperative complications.

Linked Publications

  • A Randomized Controlled Trial of Sugammadex versus Neostigmine for Reversal of Rocuronium on Gastric Emptying in Adults Undergoing Elective Colorectal Surgery.
    Anesthesia and analgesia · 2025 · 3 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Gastric Emptying
1120; 1130 0.58
SECONDARY
Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Drug.
5.2; 17.5 <0.001 sig
SECONDARY
Number of Participants With Gastrointestinal Complications
10; 19 0.087
SECONDARY
PACU Recovery Time
115; 108 0.48
SECONDARY
Reversal Time to First Bowel Movement
44.3; 61 0.02 sig
SECONDARY
Reversal Time to Discharge Order
4.8; 7.82 0.27

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years
  • Having surgery in the South Operating Rooms at Oregon Health & Science University
  • Surgery scheduled Monday through Friday
  • Having colorectal surgery
  • Planned general endotracheal anesthesia

Exclusion Criteria

  • Prisoners
  • Pregnant women
  • An inability to consent for surgery or anesthesia
  • Allergy to a study drug
  • Medical contraindication to neuromuscular blockade
  • Stage 4 kidney disease or worse (glomerular filtration rate twice the OHSU normal)
  • Taking Toremifene
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04546672) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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