Clinical trial • Other
NORADRENALINE TARTRATE for Hypotension during anesthesia
Clinical trial of NORADRENALINE TARTRATE for Hypotension during anesthesia.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Hypotension during anesthesia
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 21-06-2024
- First CTIS Authorization Date
- 04-07-2024
Trial design
Comparator arms: PHENYLEPHRINE (intravenous) and NORADRENALINE TARTRATE (intravenous); dose and schedule not specified.-controlled trial across 1 site in Denmark.
- Comparator
- Comparator arms: PHENYLEPHRINE (intravenous) and NORADRENALINE TARTRATE (intravenous); dose and schedule not specified.
- Target Sample Size
- 32
Eligibility
Recruits 32 No vulnerable population selected. Inability to give written informed consent is listed as an exclusion; written informed consent is required from participants..
- Pregnancy Exclusion
- pregnancy (positive pregnancy urine test) or breastfeeding
- Vulnerable Population
- No vulnerable population selected. Inability to give written informed consent is listed as an exclusion; written informed consent is required from participants.
Inclusion criteria
- {"criterion_text":"- Subjects aged 18-75 yr. scheduled for elective craniotomy for supratentorial tumors with a minimum size of 3 cm (measured as the largest diameter in any plane) are included"}
Exclusion criteria
- {"criterion_text":"- Exclusion criteria are history of allergy or intolerance to one of the study medications, an American Society of Anesthesiologists (ASA) physical status IV to VI, pregnancy (positive pregnancy urine test) or breastfeeding and inability to give written informed consent"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the between-group difference in ΔCBF (Δ= posttreatment value-pretreatment value).","definition_or_measurement_approach":"ΔCBF defined as posttreatment value - pretreatment value (between-group difference in ΔCBF)."}
Recruitment
- Planned Sample Size
- 32
- Recruitment Window Months
- 62
- Consent Approach
- Written informed consent is required from participants; inability to give written informed consent is an exclusion. Subject information and informed consent form documents are listed in the trial documents, but languages and age-specific assent procedures are not specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 32
Denmark
- Earliest CTIS Part Ii Submission Date
- 28-06-2024
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 514
- Number Of Sites
- 1
- Number Of Participants
- 32
Sites
- Site Name
- Region Midtjylland (Aarhus University Hospital)
- Department Name
- Anesthesiology
- Principal Investigator Name
- Mads Rasmussen
- Principal Investigator Email
- mads.rasmussen@vest.rm.dk
- Contact Person Name
- Mads Rasmussen
- Contact Person Email
- mads.rasmussen@vest.rm.dk
- Number Of Participants
- 32
Sponsor
Primary sponsor
- Full Name
- Region Midtjylland
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code 1","organisation_type":"Educational Institution"}
Investigational products
- Investigational Product Name
- NORADRENALINE TARTRATE
- Active Substance
- NORADRENALINE TARTRATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 100 mg
- Investigational Product Name
- PHENYLEPHRINE
- Active Substance
- PHENYLEPHRINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 100 mg
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