Sugammadex v.s. Neostigmine/Glycopyrrolate

Not Applicable

Not yet recruiting

• Conditions: Head and Neck Neoplasms; Chronic Otitis Media; Chronic Sinusitis

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

Brief Summary

The aim of study is to clarify the role of sugammadex in head and neck surgery patients with a prior history of 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 head and neck surgery within two hours of expected surgical time are enrolled. These patients are associated with high-risk of postoperative urinary retention, including prior history of urinary retention, benign prostatic hypertrophy, or a history of prostate cancer. They are randomly divided these patients into sugammadex group (S group) 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 head and neck surgery. Sugammadex can be recommended for these high-risk patients in the future.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-04-30
• Last Update Submitted: 2024-04-30
• Study Start: 2024-05-01
• Study First Posted: 2024-05-03
• Last Update Posted: 2024-05-03
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

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

Inclusion Criteria

• head and neck surgery patients whose surgery is expected to take less than two hours
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
postoperative urinary retention	up to 48 hours	self-voiding more than 8 hours after surgery

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan