Clinical Effects Of Continuous Infusion Of Propofol In Adults With Brugada Syndrome.

Phase 1

• Conditions: Target Controlled Infusion of Propofol in patients with Brugada Syndrome.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-004750-28-BE
• Lead Sponsor: niversitair Ziekenhuis Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-01
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

- Age = 18 year
- ASA 2, 3 or 4
- Elective surgery

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

- Known allergy to propofol
- Severe cerebral pathology
- Ketamine administration
- Nitrous Oxide administration
- Successful performed locoregional block prior to surgery
- BMI > 35 for female patients
- BMI > 42 for male patients
- Obstetric anaesthesia
- Critical Illness
- Mitochondrial disease
- Fatty acid oxidation disorder
- Co-enzyme Q deficiency
- Any condition that renders the patient unfit for elective surgery
- Surgical site interference with 12-lead ECG site (e.g. chest surgery)
- Ajmaline administration during surgery

Study & Design

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