A clinical trial to determine the doses of two anesthesia agents needed to put newborn patients to sleep.

Propofol and thiopental for intravenous induction in neonates: a dose finding study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001534-34-DK

Enrollment

160

Registered

2021-12-14

Start date

2022-03-11

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Any condition requiring general anesthesia. MedDRA version: 21.1 Level: LLT Classification code 10018061 Term: General anesthesia System Organ Class: 100000004865

Interventions

Trade Name: Propofol Pharmaceutical Form: Solution for injection INN or Proposed INN: Propofol Other descriptive name: PROPOFOL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newborns up to a postnatal age of 28 days, undergoing general anaesthesia for surgical or diagnostic procedures. 2.Informed consent from parents or guardian Are the trial subjects under 18? yes Number of subjects for this age range: 160 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1. Allergies to Thiopental or Propofol 2. Known porphyria or family history of porphyria (only Thiopental) 3. Refusal of the patient's parents/guardians to the preoperative placement of an intravenous (i.v.) line 4. Patients who are sedated at the time of the operation or have received sedation/anaesthesia 24h before induction of anaesthesia. 5. Patients who are sedated at the time of the operation or have received sedation/anaesthesia 24h before induction of anaesthesia.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the anesthetic induction dose of Propofol and Thiopental in neonates of different gestational age and postnatal age;Secondary Objective: To investigate the impact of the induction dose in neonates on systemic and cerebral haemodynamics;Primary end point(s): To determine the anesthetic induction dose requirements of Propofol and Thiopental in neonates of different gestational age and postnatal age (effective dose in 50% =ED50);Timepoint(s) of evaluation of this end point: Immediately	—

Measure

Time frame

Main Objective: To determine the anesthetic induction dose of Propofol and Thiopental in neonates of different gestational age and postnatal age;Secondary Objective: To investigate the impact of the induction dose in neonates on systemic and cerebral haemodynamics;Primary end point(s): To determine the anesthetic induction dose requirements of Propofol and Thiopental in neonates of different gestational age and postnatal age (effective dose in 50% =ED50);Timepoint(s) of evaluation of this end point: Immediately

—

Secondary

Measure	Time frame
Secondary end point(s): To investigate the impact of the induction dose on the neonatal systemic and cerebral haemodynamics;Timepoint(s) of evaluation of this end point: Immediately	—

Countries

Denmark

Contacts

Public ContactKristian Nørholm Jensen

Odense University Hospital

kristian.noerholm.jensen@rsyd.dk+4520620531

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026