Overview
Sponsor-declared trial summary
Detection of residual neuromuscular blockade after extubation by measuring upper airway diameter
The differences in retroglossal pharyngeal cross sectional areas (inspiration and exspiration) measured at different train of four TOF values, and changes in these values compared to (initial) retroglossae pharyngeal areas detected before administration of muscle relaxants. Areas are measured in pixels and the rate of …
Key facts
- Sponsor
- University Of Debrecen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2025-01-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519777-19-00
- EudraCT number
- 2022-004113-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The differences in retroglossal pharyngeal cross sectional areas (inspiration and exspiration) measured at different train of four TOF values, and changes in these values compared to (initial) retroglossae pharyngeal areas detected before administration of muscle relaxants. Areas are measured in pixels and the rate of reduction of areas is expressed as a percentage.
Conditions and MedDRA coding
Detection of residual neuromuscular blockade after extubation by measuring upper airway diameter
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10057286 | Neuromuscular blockade reversal | 100000004865 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Age: 18-65 years; ASA 1-3; BMI 18.5-25 (normal body weight); men/women in equal proportion; duration of surgeries at least ≥ 30 minutes; intervention requiring intratracheal intubation; patients are in a supine position.
Exclusion criteria 1
- drugs affecting neuromuscular function (magnesium, aminoglycosides); difficult airway, expected difficult intubation; pregnancy (pregnancy test for women of childbearing age to rule out pregnancy we finish); breastfeeding; acute surgery; COPD glaucoma
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The differences in retroglossal pharyngeal cross sectional areas (inspiration and exspiration) measured at different TOF values
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Sugammadex Amomed 100 mg/ml solution for injection
PRD10155926 · Product
- Active substance
- Sugammadex
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 32 mg/kg milligram(s)/kilogram
- Max total dose
- 32 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AB35 — -
- Marketing authorisation
- EU/1/22/1708/001
- MA holder
- AOP ORPHAN PHARMACEUTICALS GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Esmeron 10 mg/ml oldatos injekció
PRD363950 · Product
- Active substance
- Rocuronium Bromide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1.2 mg/kg milligram(s)/kilogram
- Max total dose
- 1.2 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AC09 — ROCURONIUM BROMIDE
- Marketing authorisation
- OGYI-T-8863/03
- MA holder
- MSD PHARMA HUNGARY KFT.
- MA country
- Hungary
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of Debrecen
- Sponsor organisation
- University Of Debrecen
- Address
- Nagyerdei Korut 98
- City
- Debrecen
- Postcode
- 4032
- Country
- Hungary
Scientific contact point
- Organisation
- University Of Debrecen
- Contact name
- Dr. Asztalos László
Public contact point
- Organisation
- University Of Debrecen
- Contact name
- Dr. Asztalos László
Sponsor responsibilities
- Article 77 compliance
- University Of Debrecen
- Contact point sponsor
- University Of Debrecen
- Article 77 implementation
- University Of Debrecen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Authorised, recruitment pending | 75 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protokoll | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Betegtajekoztato es beleegyezo nyilatkozat legut | 1.2. |
| Summary of Product Characteristics (SmPC) (for publication) | sugammadex-amomed-epar-product-information_hu | 1 |
| Synopsis of the protocol (for publication) | szinopszis | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-26 | Hungary | Acceptable 2025-01-03
|
2025-01-03 |