Sugammadex v.s. Neostigmine/Glycopyrrolate

Sugammadex Compared With Neostigmine/Glycopyrrolate in Impact of Postoperative Urinary Retention for ENT Surgery Patients With High-risk of Dysuria

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.

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis; Laryngeal Disease; Chronic Otitis Media; Head and Neck Surgery
• Intervention / Treatment: Drug: Group S: sugammadex injection; Drug: Group N: neostigmine/glycopyrrolate

Detailed Description

Investigators will evaluate the benefit of sugammadex in reducing postoperative urinary retention for these head and neck surgery patients with high-risk for dysuria. The definition of high-risk of dysuria is patient with a prior history of urinary retention, benign prostatic hypertrophy, or a history of prostate cancer.

Patients scheduled to undergo ENT surgery within Three hours of expected surgical time are enrolled. These patients are associated with high-risk of postoperative urinary retention, including prior history of postoperative urinary retention, benign prostatic hypertrophy, or a history of prostate cancer. They are randomly divided these patients into sugammadex group (Group S) and neostigmine/glycopyrrolate group (Group N), sugammadex or neostigmine/glycopyrrolate are used during recovery period of anesthesia, to compare the incidences of postoperative urinary retention, nausea/vomiting, bradycardia, hypotension, and dry mouth in these patients after ENT surgery. Sugammadex can be recommended for these high-risk patients in the future.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group S; Sugammadex as reversal agent	Drug: Group S: sugammadex injection; Reversal agent: sugammadex; Other Names: Bridion
Active Comparator: Group N; neostigmine and glycopyrrolate as reversal agent	Drug: Group N: neostigmine/glycopyrrolate; Reversal agent: glycopyrrolate and neostigmine; Other Names: vagostin injection/glycopyrodyn

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative nausea and vomiting	postoperative nausea and vomiting	48 hours
bradycardia	Bradycardia was defined as a heart rate of less than 50 beats per minute.	24 hours
thirsty intensity	thirsty intensity during postanesthesia care unit	24 hour
length of hospital stay	length of hospital stay	during admission (assessed up to 7 days)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: PEILIN LN, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): June 12, 2025
• Study Completion (Actual): August 12, 2025

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Sugammadex; neostigmine; ENT surgery; postoperative urinary retention; anticholinergic drug
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates; Polycyclic Compounds; Amines; Polysaccharides; Macrocyclic Compounds; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; gamma-Cyclodextrins; Cyclodextrins; Dextrins; Starch; Glucans; Glycopyrrolate; Sugammadex
• Other Study ID Numbers: 202307081MINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No