Sugammadex v.s. Neostigmine/Glycopyrrolate

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398899
• Other study ID #: 202307081MINA
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: National Taiwan University Hospital
• Contact: PEILIN LIN
• Phone: +886972651605
• Email: pll5611[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Otitis Media
• Chronic Sinusitis
• Head and Neck Neoplasms
• Otitis Media
• Sinusitis
• Urinary Retention

Intervention

Drug:
• 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
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative urinary retention	self-voiding more than 8 hours after surgery	up to 48 hours