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Effect of patient-controlled sedation with propofol on patient satisfaction

Effect of patient-controlled sedation with propofol on patient satisfaction: a randomised study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81377748
Enrollment
60
Registered
2013-04-16
Start date
2000-01-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Diagnostic cerebral angiography Signs and Symptoms

Interventions

We randomly assigned 61 patients to receive propofol-based PCS (n = 33, 15 mg bolus in 9 s) or placebo-based PCS (n = 28, bolus of 1.5 mL of a 20% lipid emulsion in 9 s).

Sponsors

Assistance Publique ? Hôpitaux de Marseille AP-HM (France)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age under 70 years 2. ASA physical status below 3 3. Scheduled cerebral angiography 4. Consultation with an anesthetist at least 48 hours before the procedure

Exclusion criteria

Exclusion criteria: 1. Age under 18 years, 2. Emergency context 3. History of psychiatric disease 4, Long-course anxiolytic treatment 5. Counter-indication to propofol 6. Withdrawal of consent

Design outcomes

Primary

MeasureTime frame
The main objective was to evaluate whether a propofol-based PCS would lead at least to 20% difference in patients? satisfaction on the EVAN scale, which was self reported the day after the procedure.

Secondary

MeasureTime frame
Secondary objectives were to assess the quality of patient conditioning by the neuroradiologist and the anesthetist and to report possible side effect.

Countries

France

Outcome results

None listed

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