Clinical trial

Sugammadex Compared With Neostigmine/Glycopyrrolate in Impact of Postoperative Urinary Retention for Head and Neck Surgery Patients With High Risk of Dysuria

Name
202307081MINA
Description
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.
Trial arms
Trial start
2024-05-01
Estimated PCD
2024-12-31
Trial end
2025-01-31
Status
Not yet recruiting
Treatment
Group S: sugammadex injection
Reversal agent: sugammadex no TOF (train-of-four) response, Sugammadex 4 mg/kg TOF count is ≥ 1, Sugammadex 2 mg/kg
Arms:
Group S
Group N: neostigmine/glycopyrrolate
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.
Arms:
Group N
Size
124
Primary endpoint
postoperative urinary retention
up to 48 hours
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 124, 'type': 'ESTIMATED'}}
Updated at
2024-05-03

1 organization

2 products

3 indications

Product
Sugammadex