National Taiwan University Hospital
Taipei, 100, Taiwan
NCT Number: NCT06398899
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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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Taipei, 100, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Reversal agent: sugammadex
Other names: Bridion
Reversal agent: glycopyrrolate and neostigmine
Other names: vagostin injection/glycopyrodyn
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.
Time frame: 48 hours
postoperative nausea and vomiting
Time frame: 24 hours
Bradycardia was defined as a heart rate of less than 50 beats per minute.
Time frame: 24 hour
thirsty intensity during postanesthesia care unit
Time frame: during admission (assessed up to 7 days)
length of hospital stay
National Taiwan University Hospital
Other
Sugammadex Compared With Neostigmine/Glycopyrrolate in Impact of Postoperative Urinary Retention for ENT Surgery Patients With High-risk of Dysuria
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