Sugammadex To IMprove Bowel Function

NCT04546672 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 21895MISP #60224
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bowel Dysfunction; Postoperative Complications; Neuromuscular Blockade

Keywords

sugammadex; neostigmine; Gastric emptying; neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• Gastric Emptying

  Gastric emptying as assessed by the area under the paracetamol concentration-time curve by trapezoidal approximation (AUC)

  150 minutes after neuromuscular reversal

Secondary Outcomes (5)

• Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Drug.

  30 minutes after the administration of reversal drug.

• Number of Participants With Gastrointestinal Complications

  30 days after surgery

• PACU Recovery Time

  1 day

• Reversal Time to First Bowel Movement

  length hospitalization, an average of 1 week

• Reversal Time to Discharge Order

  length of hospitalization, an average of 1 week

Study Arms (2)

Sugammadex

EXPERIMENTAL

Sugammadex 2 mg/kg IV once at the end of surgery

Drug: Sugammadex

Neostigmine

ACTIVE COMPARATOR

Neostigmine 0.07 mg/kg to a maximum of 5 mg (+Glycopyrrolate 0.2 mg per 1 mg of neostigmine administered) IV once at the end of surgery

Drug: Neostigmine

Interventions

Sugammadex DRUG

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

Also known as: Org 25969, Bridion

Sugammadex

Neostigmine DRUG

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

Also known as: Prostigmin, Vagostigmin

Neostigmine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Togioka BM, Rakshe SK, Ye S, Tekkali P, Tsikitis VL, Fang SH, Herzig DO, Lu KC, Aziz MF. A Randomized Controlled Trial of Sugammadex versus Neostigmine for Reversal of Rocuronium on Gastric Emptying in Adults Undergoing Elective Colorectal Surgery. Anesth Analg. 2025 Aug 1;141(2):373-383. doi: 10.1213/ANE.0000000000007518. Epub 2025 May 6.

  PMID: 40327558 DERIVED

MeSH Terms

Conditions

Intestinal Diseases; Postoperative Complications

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Results Point of Contact

• Title: Dr. Brandon Togioka
• Organization: Oregon Health & Science University

togioka@ohsu.edu

503-494-4572

Study Officials

• Brandon M Togioka, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research-Anesthesiology

Model Details: Assessor-blinded, randomized, controlled, single center, parallel design trial with patient masking

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: September 14, 2020
• Study Start: March 16, 2021
• Primary Completion: June 14, 2023
• Study Completion: August 13, 2023
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)