Clinical trial • Not applicable • Other
SUGAMMADEX for Residual neuromuscular blockade | Neuromuscular blockade reversal
Not applicable trial of SUGAMMADEX for Residual neuromuscular blockade | Neuromuscular blockade reversal.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Residual neuromuscular blockade | Neuromuscular blockade reversal
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 26-11-2024
- First CTIS Authorization Date
- 03-01-2025
Trial design
open-label, esmeron (rocuronium bromide) 10 mg/ml solution for injection — comparator; maximum dose reported 1.2 mg/kg iv.-controlled Not applicable trial across 1 site in Hungary.
- Open Label
- Yes
- Comparator
- Esmeron (rocuronium bromide) 10 mg/ml solution for injection — comparator; maximum dose reported 1.2 mg/kg IV.
- Target Sample Size
- 75
Eligibility
Recruits 75 No vulnerable populations selected; participants are adults aged 18-65. Informed consent required; subject information and informed consent form available (document present). Assent not applicable..
- Pregnancy Exclusion
- pregnancy (pregnancy test for women of childbearing age to rule out pregnancy we finish)
- Vulnerable Population
- No vulnerable populations selected; participants are adults aged 18-65. Informed consent required; subject information and informed consent form available (document present). Assent not applicable.
Inclusion criteria
- {"criterion_text":"- Age: 18-65 years\n- ASA 1-3\n- BMI 18.5-25 (normal body weight)\n- men/women in equal proportion\n- duration of surgeries at least ≥ 30 minutes\n- intervention requiring intratracheal intubation\n- patients are in a supine position."}
Exclusion criteria
- {"criterion_text":"- drugs affecting neuromuscular function (magnesium, aminoglycosides)\n- difficult airway, expected difficult intubation\n- pregnancy (pregnancy test for women of childbearing age to rule out pregnancy we finish)\n- breastfeeding\n- acute surgery\n- COPD glaucoma"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The differences in retroglossal pharyngeal cross sectional areas (inspiration and exspiration) measured at different TOF values","definition_or_measurement_approach":"Differences in retroglossal pharyngeal cross sectional areas (inspiration and expiration) measured at different train-of-four (TOF) values; areas are measured in pixels and the rate of reduction of areas is expressed as a percentage."}
Recruitment
- Planned Sample Size
- 75
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent required from each participant (adults 18-65). Subject information and informed consent form available (document: 'Subject information and informed consent form' / Hungarian title present). No assent procedure (not applicable for adult participants).
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 75
Hungary
- Earliest CTIS Part Ii Submission Date
- 02-01-2025
- Latest Decision Or Authorization Date
- 03-01-2025
- Processing Time Days
- 1
- Number Of Sites
- 1
- Number Of Participants
- 75
Sites
- Site Name
- University Of Debrecen (Nagyerdei Korut 98)
- Department Name
- FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care
- Principal Investigator Name
- László Asztalos
- Principal Investigator Email
- asztalos.laszlo@med.unideb.hu
- Contact Person Name
- László Asztalos
- Contact Person Email
- asztalos.laszlo@med.unideb.hu
- Number Of Participants
- 75
Sponsor
Primary sponsor
- Full Name
- University Of Debrecen
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Hungary
Investigational products
- Investigational Product Name
- Sugammadex Amomed 100 mg/ml solution for injection
- Active Substance
- SUGAMMADEX
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation: EU/1/22/1708/001)
- Maximum Dose
- 32 mg/kg
- Investigational Product Name
- Esmeron 10 mg/ml oldatos injekció
- Active Substance
- ROCURONIUM BROMIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation: OGYI-T-8863/03, national authorisation Hungary)
- Maximum Dose
- 1.2 mg/kg
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