Clinical trial • Other

THIOPENTAL SODIUM for Neonatal general anaesthesia

Clinical trial of THIOPENTAL SODIUM for Neonatal general anaesthesia. 160 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Neonatal general anaesthesia
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
08-10-2024
First CTIS Authorization Date
23-10-2024

Trial design

Clinical trial across 1 site in Denmark.

Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
160
Trial Duration For Participant
1

Eligibility

Recruits 160 paediatric patients.

Vulnerable Population
Neonates are identified as a vulnerable population (isVulnerablePopulationSelected=true). Consent is handled via parents/guardians: subject information and informed consent forms are provided for parents and guardians (documents: L1_ICF For parents and guardians; L1_SIS for parents and guardians). Assent is not applicable for neonates.

Inclusion criteria

  • {"criterion_text":"- Neonates <47 weeks postmenstrual age (PMA) undergoing general anesthesia (GA) for any condition"}

Exclusion criteria

  • {"criterion_text":"- 1. Allergies towards propofol or thiopental\n- 2. Known or family history of porphyria (thiopental only)\n- 3. Parental refusal of insertion of an iv-line.\n- 4. sedation within last 24 hours\n- 5. Contraindication to propofol or thiopental according to the attending anesthesiologist, not mentioned above."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Loss of eyelash reflex and acceptance of facemask","definition_or_measurement_approach":"Measured as loss of eyelash reflex and acceptance of facemask (endpoint text provided in CTIS: \"Loss of eyelash reflex and acceptance of facemask\")."}

Recruitment

Planned Sample Size
160
Recruitment Window Months
74
Consent Approach
Informed consent obtained from parents/guardians. Subject information and informed consent forms are available for parents and guardians (documents: L1_ICF For parents and guardians; L1_SIS for parents and guardians). Assent is not applicable for neonates.

Geography

Total Number Of Sites
1
Total Number Of Participants
160

Denmark

Earliest CTIS Part Ii Submission Date
10-10-2024
Latest Decision Or Authorization Date
23-10-2024
Processing Time Days
13
Number Of Sites
1
Number Of Participants
160

Sites

Site Name
Odense University Hospital
Department Name
Anesthesiology and intensive care
Principal Investigator Name
Kristian Nørholm Jensen
Principal Investigator Email
kristian.noerholm.jensen@rsyd.dk
Contact Person Name
Kristian Nørholm Jensen

Sponsor

Primary sponsor

Full Name
Odense University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"codes: 1, 7, 8","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Tiomebumalnatrium SAD, injektionsvæske, opløsning
Active Substance
THIOPENTAL SODIUM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation number 16534 (Denmark)
Maximum Dose
5 mg/kg
Investigational Product Name
Propofol B. Braun 1% (10 mg/ml) emulsione iniettabile o per infusione.
Active Substance
PROPOFOL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS USE
Route
INTRAVENOUS BOLUS
Authorisation Status
Marketing authorisation number 035911054 (authorisationCountryCode: IT), MRP number DE/H/0185/001
Maximum Dose
3 mg/kg

Related trials

Other published trials that may interest you.