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

Phase 1

• Conditions: Any condition requiring general anesthesia.; MedDRA version: 21.1Level: LLTClassification code 10018061Term: General anesthesiaSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-001534-34-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-14
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified