NCT06398899

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Group S: sugammadex injection	Reversal agent: sugammadex
DRUG	Group N: neostigmine/glycopyrrolate	Reversal agent: glycopyrrolate and neostigmine

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-06-12
• Completion: 2025-08-12
• First posted: 2024-05-03
• Last updated: 2025-09-12

Locations

1 site across 1 country: Taiwan