Sugammadex v.s. Neostigmine/Glycopyrrolate

National Taiwan University

Status: Completed

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

Treatments: Drug: Group N: neostigmine/glycopyrrolate; Drug: Group S: sugammadex injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06398899

202307081MINA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups

Group S

Experimental group

Description:

Sugammadex as reversal agent

Treatment:

Drug: Group S: sugammadex injection

Group N

Active Comparator group

Description:

neostigmine and glycopyrrolate as reversal agent

Treatment:

Drug: Group N: neostigmine/glycopyrrolate