Phase 4
N=120
Sugammadex To IMprove Bowel Function
Bowel Dysfunction · Postoperative Complications · Neuromuscular Blockade
Bottom Line
View on ClinicalTrials.gov: NCT04546672 ↗Enrolled (actual)
120
Serious AEs
5.8%
Results posted
Jul 2024
Primary outcome: Primary: Gastric Emptying — 1120; 1130 log(ng*ml-1)*min — p=0.58
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex (Drug); Neostigmine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-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 |
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.
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
Data sourced from ClinicalTrials.gov (NCT04546672). 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.