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Clinical trial

An Assessor-blinded, Randomized, Controlled, Single Center, Parallel Design Trial With Patient Masking to Compare Early Postoperative Gastric Emptying Associated With Rocuronium Neuromuscular Reversal With Sugammadex Versus Neostigmine in Adults Undergoing Colon and Rectal Surgery

ID
Name
21895
Description
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.
Trial arms
Trial start
2021-03-16
Estimated PCD
2023-07-14
Trial end
2024-07-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Sugammadex
At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg actual body weight through an intravenous line with brisk flow
Arms:
Sugammadex
Other names:
Org 25969, Bridion
Neostigmine
At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg actual body weight to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be coadministered with Neostigmine at a dose of 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered
Arms:
Neostigmine
Other names:
Prostigmin, Vagostigmin
Size
120
Primary endpoint
Gastric emptying
0, 15, 30, 45, 60, 90, 120, and 150 minutes after neuromuscular reversal
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 \< 30 ml/min) * Significant liver dysfunction (Aspartate transaminase or Alanine transaminase \> twice the OHSU normal) * Taking Toremifene
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Assessor-blinded, randomized, controlled, single center, parallel design trial with patient masking', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2023-11-02

1 organization

2 products

3 indications

Organization
Oregon Health and Science University
Product
Sugammadex
Indication
Bowel Dysfunction
Indication
Postoperative Complications
Indication
Neuromuscular Blockade
Product
Neostigmine