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Trial Title:
Sugammadex v.s. Neostigmine/Glycopyrrolate
NCT ID:
NCT06398899
Condition:
Head and Neck Neoplasms
Chronic Sinusitis
Chronic Otitis Media
Conditions: Official terms:
Sinusitis
Head and Neck Neoplasms
Otitis Media
Urinary Retention
Glycopyrrolate
Neostigmine
Conditions: Keywords:
Sugammadex
anticholinergic drug
postoperative urinary retention
head and neck surgery
neostigmine
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Group S: sugammadex injection
Description:
Reversal agent: sugammadex no TOF (train-of-four) response, Sugammadex 4 mg/kg TOF count
is ≥ 1, Sugammadex 2 mg/kg
Arm group label:
Group S
Intervention type:
Drug
Intervention name:
Group N: neostigmine/glycopyrrolate
Description:
Reversal agent: glycopyrrolate and neostigmine. TOF 2-3, neostigmine 50 µg/kg; TOF 4,
neostigmine 20-40 µg/kg For all patients, glycopyrrolate 0.4 mg is co-administered with
neostigmine.
Arm group label:
Group N
Summary:
The aim of study is to clarify the role of sugammadex in head and neck surgery patients
with a prior history of 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 head and neck surgery within two hours of expected surgical
time are enrolled. These patients are associated with high-risk of postoperative urinary
retention, including prior history of urinary retention, benign prostatic hypertrophy, or
a history of prostate cancer. They are randomly divided these patients into sugammadex
group (S group) 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 head and neck surgery. Sugammadex can be
recommended for these high-risk patients in the future.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- head and neck surgery patients whose surgery is expected to take less than two hours
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Contact:
Last name:
PEILIN LIN
Phone:
+886972651605
Email:
pll5611@ntu.edu.tw
Start date:
May 1, 2024
Completion date:
January 31, 2025
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06398899
