Clinical trial • Other

Sugammadex for Neuromuscular blockade

Clinical trial of Sugammadex for Neuromuscular blockade. Randomised. 80 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Neuromuscular blockade
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
21-03-2025
First CTIS Authorization Date
16-06-2025

Trial design

Randomised trial across 1 site in Hungary.

Randomised
Yes
Target Sample Size
80

Eligibility

Recruits 80 No vulnerable population selected (isVulnerablePopulationSelected=false). Consent/assent handling not specified..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected=false). Consent/assent handling not specified.

Recruitment

Planned Sample Size
80
Recruitment Window Months
45

Geography

Total Number Of Sites
1
Total Number Of Participants
80

Hungary

Earliest CTIS Part Ii Submission Date
27-02-2025
Latest Decision Or Authorization Date
16-06-2025
Processing Time Days
109
Number Of Sites
1
Number Of Participants
80

Sites

Site Name
University Of Debrecen
Department Name
FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care
Principal Investigator Name
László Asztalos
Principal Investigator Email
asztaloslasz@gmail.com
Contact Person Name
László Asztalos
Contact Person Email
asztaloslasz@gmail.com

Sponsor

Primary sponsor

Full Name
University Of Debrecen
Organisation Type
Educational Institution
Country Of Registered Address
Hungary

Investigational products

Investigational Product Name
Sugammadex
Active Substance
Sugammadex
Modality
Small molecule

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