Clinical trial • Phase IV • Other
glycopyrronium bromide | neostigmine methylsulfate for Residual neuromuscular blockade (reappearance of non-depolarizing neuromuscular block after reversal with neostigmine)
Phase IV trial of glycopyrronium bromide | neostigmine methylsulfate for Residual neuromuscular blockade (reappearance of non-depolarizing neuromuscular b…
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Residual neuromuscular blockade (reappearance of non-depolarizing neuromuscular block after reversal with neostigmine)
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 05-09-2024
- First CTIS Authorization Date
- 17-09-2024
Trial design
Phase IV trial across 1 site in Finland.
- Target Sample Size
- 120
Eligibility
Recruits 120 No vulnerable population selected; participants are adults (AGE 18-65) and no special consent/assent handling is described in the available record..
- Vulnerable Population
- No vulnerable population selected; participants are adults (AGE 18-65) and no special consent/assent handling is described in the available record.
Inclusion criteria
- {"criterion_text":"- To find the incidence of reappearance of nondepolarizing neuromuscular block after reversal with neostigmine."}
- {"criterion_text":"- Body Mass Index (BMI) <35k9/ mz"}
- {"criterion_text":"- AGE 18-65 years"}
- {"criterion_text":"- ASA risk class 1-2"}
Exclusion criteria
- {"criterion_text":"- Disease or previous injury of central nervous system"}
- {"criterion_text":"- Disease or medication affecting peripheral nervous system"}
Endpoints
Primary endpoints
- {"endpoint_text":"- To find the incidence of reappearance of nondepolarizing neuromuscular block after reversal with neostigmine","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 120
- Recruitment Window Months
- 84
- Consent Approach
- Informed consent required from participants (AGE 18-65). Subject information and informed consent form documents are listed in the trial documents, but the content and available languages are not available in the provided data.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 120
Finland
- Earliest CTIS Part Ii Submission Date
- 05-09-2024
- Latest Decision Or Authorization Date
- 17-09-2024
- Processing Time Days
- 12
- Number Of Sites
- 1
- Number Of Participants
- 120
Sites
- Site Name
- Tampere University Hospital
- Department Name
- Anestesia ja tehohoito
- Principal Investigator Name
- Maija-Liisa Kalliomäki
- Principal Investigator Email
- maija-liisa.kalliomaki@pirha.fi
- Contact Person Name
- Maija-Liisa Kalliomäki
- Contact Person Email
- maija-liisa.kalliomaki@pirha.fi
Sponsor
Primary sponsor
- Full Name
- Pirkanmaan hyvinvointialue
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- GLYCOSTIGMIN -injektioneste, liuos
- Active Substance
- glycopyrronium bromide | neostigmine methylsulfate
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- Authorised (marketing authorisation FI 10970)
- Maximum Dose
- Max daily/total amount listed as 1 ml
- Combination Treatment
- Yes
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