Sugammadex v.s. Neostigmine/Glycopyrrolate

NCT06398899 | Completed DMC

• 1 other identifier: 202307081MINA
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of study is to clarify the role of sugammadex in ENT surgery patients with a prior history of postoperative urinary retention, benign prostatic hypertrophy, or a history of prostate cancer, to prevent postoperative urinary retention. The main question it aims to answer are:

• Anticholinergic agent interferes the postoperative urination
• Sugammadex does not interfere postoperative urination Sugammadex can be recommended for these patients with high risk in postoperative urinary retention in the future.

Conditions

Head and Neck Surgery; Chronic Sinusitis; Chronic Otitis Media; Laryngeal Disease

Keywords

Sugammadex; anticholinergic drug; postoperative urinary retention; ENT surgery; neostigmine

Outcome Measures

Primary Outcomes (1)

• postoperative urinary retention

  Postoperative urinary retention is defined as patient discomfort or a palpable bladder, with a bladder volume of ≥400 mL confirmed by bladder scan or catheterization, requiring intervention.

  up to 48 hours

Secondary Outcomes (4)

• postoperative nausea and vomiting

  48 hours

• bradycardia

  24 hours

• thirsty intensity

  24 hour

• length of hospital stay

  during admission (assessed up to 7 days)

Study Arms (2)

Group S

EXPERIMENTAL

Sugammadex as reversal agent

Drug: Group S: sugammadex injection

Group N

ACTIVE COMPARATOR

neostigmine and glycopyrrolate as reversal agent

Drug: Group N: neostigmine/glycopyrrolate

Interventions

Group S: sugammadex injection DRUG

Reversal agent: sugammadex

Also known as: Bridion

Group S

Group N: neostigmine/glycopyrrolate DRUG

Reversal agent: glycopyrrolate and neostigmine

Also known as: vagostin injection/glycopyrodyn

Group N

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ENT surgery patients whose surgery is expected to take less than three hours and no planned Foley catheter
• high risk of postoperative urinary retention, including
• prior history of postoperative urinary retention
• benign prostatic hypertrophy
• history of prostate cancer

You may not qualify if:

• refusal or inability to provide informed consent
• age younger than 18 years
• American Society of Anesthesiologists class more than III
• pregnancy
• impaired renal function (creatinine clearance \< 30 mL/min)
• allergy to a study drug

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Laryngeal Diseases

Interventions

Sugammadex; Glycopyrrolate

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• PEILIN LN

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sugammadex or Neostigmine/Glycopyrrolate

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: May 3, 2024
• Study Start: May 1, 2024
• Primary Completion: June 12, 2025
• Study Completion: August 12, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-08

Locations

TW (1)