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Completed

NCT Number: NCT06398899

Sugammadex v.s. Neostigmine/Glycopyrrolate

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group S: sugammadex injection

Drug

Reversal agent: sugammadex

Other names: Bridion

Group N: neostigmine/glycopyrrolate

Drug

Reversal agent: glycopyrrolate and neostigmine

Other names: vagostin injection/glycopyrodyn

Primary outcomes

  1. postoperative urinary retention

    Time frame: 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 outcomes

  1. postoperative nausea and vomiting

    Time frame: 48 hours

    postoperative nausea and vomiting

  2. bradycardia

    Time frame: 24 hours

    Bradycardia was defined as a heart rate of less than 50 beats per minute.

  3. thirsty intensity

    Time frame: 24 hour

    thirsty intensity during postanesthesia care unit

  4. length of hospital stay

    Time frame: during admission (assessed up to 7 days)

    length of hospital stay

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Sugammadex Compared With Neostigmine/Glycopyrrolate in Impact of Postoperative Urinary Retention for ENT Surgery Patients With High-risk of Dysuria

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 3, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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