Sedation during ventricular tachycardia treatment

Sedation with propofol and remifentanil during ventricular tachycardia treatment: patient-controlled versus nurse anesthetists controlled - a randomized controlled trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004455-78-SE

Enrollment

100

Registered

2017-04-11

Start date

2017-06-09

Completion date

Unknown

Last updated

2017-11-13

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

Conditions

Percutaneous pericardial access for mapping and ablation of ventricular tachycardia

Interventions

Product Name: Propofol Pharmaceutical Form: Emulsion for injection/infusion INN or Proposed INN: Propofol CAS Number: 2078-54-8 Other descriptive name: PROPOFOL Concentration unit: mg/ml milligram(s)/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults (>18 yr) Patients in need of ablation for ventricular tachycardia That the patients have given their signed consent to participate, after receiving information Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Known pregnancy or planning to be pregnant Known allergy or contraindication to any of the studied drugs Cognitive impairment, unwillingness or language difficulties that may impend the understanding of what participation in the study means or the operating of the PCS devise.

Design outcomes

Primary

Measure	Time frame
Main Objective: We hypothesise that patient-controlled remifentanil and propofol sedation for the treatment of ventricular tachycardia will result in good treatability, well accepted for the patient and short time for recovery, compared with remifentanil and propofol sedation given by nurse anesthetists. ;Secondary Objective: We also hypothesise that patient-controlled sedation is safe and that patient characteristics affect the doses of drugs given by the patients. ;Primary end point(s): Treatability: if the ablation have to be performed differently according to insufficient sedation or time delay. ;Timepoint(s) of evaluation of this end point: Day of ablation	—

Measure

Time frame

Main Objective: We hypothesise that patient-controlled remifentanil and propofol sedation for the treatment of ventricular tachycardia will result in good treatability, well accepted for the patient and short time for recovery, compared with remifentanil and propofol sedation given by nurse anesthetists. ;Secondary Objective: We also hypothesise that patient-controlled sedation is safe and that patient characteristics affect the doses of drugs given by the patients. ;Primary end point(s): Treatability: if the ablation have to be performed differently according to insufficient sedation or time delay. ;Timepoint(s) of evaluation of this end point: Day of ablation

—

Secondary

Measure	Time frame
Secondary end point(s): Procedure variables: mapping and treatment time Sedation variables: level of sedation, doses of drugs given, patients vital signs, recovery time Patients variables: characteristics of the patients from Pain catastrophizing scale and Perceived stress scale, patients satisfaction, comfort and pain levels during the treatment;Timepoint(s) of evaluation of this end point: Day of ablation	—

Measure

Time frame

Secondary end point(s): Procedure variables: mapping and treatment time Sedation variables: level of sedation, doses of drugs given, patients vital signs, recovery time Patients variables: characteristics of the patients from Pain catastrophizing scale and Perceived stress scale, patients satisfaction, comfort and pain levels during the treatment;Timepoint(s) of evaluation of this end point: Day of ablation

—

Countries

Sweden

Contacts

Public ContactThorax-kärlkliniken

Region Östergötland

eva.ahlgren.andersson@regionostergotland.se

Outcome results

None listed

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