Sugammadex v.s. Neostigmine/Glycopyrrolate

Not Applicable

Completed

• Conditions: Head and Neck Surgery; Chronic Sinusitis; Chronic Otitis Media; Laryngeal Disease

• Registration Number: NCT06398899
• Lead Sponsor: National Taiwan University Hospital

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.

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 Timeline

• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-04-30
• Study Start: 2024-05-01
• Study First Posted: 2024-05-03
• Primary Completion: 2025-06-12
• Status Verified: 2025-08
• Study Completion: 2025-08-12
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
postoperative urinary retention	up to 48 hours	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan