Safety and Effectiveness using DEXmedetomidine sedation versus Propofol/Alfentanil sedation during oesophagus interventions. (SEDEX)

Phase 3

Completed

• Conditions: gullet cancer; oesophagus cancer; 10017990

• Registration Number: NL-OMON35831
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

Age range * 18 years
ASA classification I * III
Patients, undergoing elective oesophagus intervention
Written informed consent

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 (rate < 50) and / or related bradydysrhymias (e.g. advanced heart block)
Impaired ventricular functions (EF <30%)
GFR less than 15ml/min or undergoing hemodialysis
End stage liver disease
Substance abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters, reflecting the safety aspect, are measurement of oxygen<br /><br>saturation (SO2) measured by pulse oximetry, exhaled CO2 (capnography), heart<br /><br>rate, arrhythmias (ECG) and blood pressure (non-invasive blood pressure<br /><br>measurement, NIBP) and non-invasive cardiac output monitoring (Nexfin). These<br /><br>hemodynamic parameters are surrogate parameters of pulmonary and cardiovascular<br /><br>problems, experienced by the patient during sedation.<br /><br>Further study parameters measure the effectiveness of the reached sedation<br /><br>level. These parameters are collected by means of questionnaires before and<br /><br>after the procedure and on the following day. We will also measure sweat<br /><br>conductance as a indicator for patients stress level during the procedure.<br /><br><br /><br>. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>