Sugammadex v.s. Neostigmine/Glycopyrrolate

NCT ID: NCT06398899

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-08-12

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group S

Sugammadex as reversal agent

Group Type: EXPERIMENTAL

Group S: sugammadex injection

Intervention Type: DRUG

Reversal agent: sugammadex

Group N

neostigmine and glycopyrrolate as reversal agent

Group Type: ACTIVE_COMPARATOR

Group N: neostigmine/glycopyrrolate

Intervention Type: DRUG

Reversal agent: glycopyrrolate and neostigmine

Interventions

Group S: sugammadex injection

Reversal agent: sugammadex

Intervention Type: DRUG

Group N: neostigmine/glycopyrrolate

Reversal agent: glycopyrrolate and neostigmine

Intervention Type: DRUG

Other Intervention Names

Bridion; vagostin injection/glycopyrodyn

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PEILIN LN

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202307081MINA

Identifier Type: -

Identifier Source: org_study_id