Patient and gastroenterologist satisfaction with different forms of sedation during oesophagus intervention.

• Conditions: Patients undergoing therapeutically esophageal interventions under sedation (dexmedetomidine or propofol/alfentanil) given by trained anesthesia nurse.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004206-19-NL
• Lead Sponsor: AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-07
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

The patients must comply with the following criteria in order to be eligible to participate in this clinical study:
Age range = 18 years
ASA classification I – III
Patients, undergoing elective oesophagus intervention
Written informed consent

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 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Age range < 18 years
ASA classification IV and V
Allergic reaction to planned medication in the patients’ medical history
Unregulated hypertension
Hypovolemia or hypotension (SBP <80 or MAP <50)
Sever bradycardia (heartrate < 50) and / or related bradydysrhytmias (e.g. advanced heart block)
Impaired ventricular function (EF <30%)
GFR less than 15ml/min or undergoing hemodialysis
End stage liver disease
Substance abuse

Study & Design

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