Chronic Otitis Media, Chronic Sinusitis, Head and Neck Surgery, Laryngeal Disease
Conditions
Keywords
Sugammadex, anticholinergic drug, postoperative urinary retention, ENT surgery, neostigmine
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.
Interventions
DRUGGroup S: sugammadex injection
Reversal agent: sugammadex
DRUGGroup N: neostigmine/glycopyrrolate
Reversal agent: glycopyrrolate and neostigmine
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Sugammadex or Neostigmine/Glycopyrrolate
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative urinary retention | 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
| Measure | Time frame | Description |
|---|---|---|
| postoperative nausea and vomiting | 48 hours | postoperative nausea and vomiting |
| bradycardia | 24 hours | Bradycardia was defined as a heart rate of less than 50 beats per minute. |
| thirsty intensity | 24 hour | thirsty intensity during postanesthesia care unit |
| length of hospital stay | during admission (assessed up to 7 days) | length of hospital stay |
Countries
Taiwan
Outcome results
None listed