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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35831

Enrollment

Registered

2011-09-05

Start date

2012-07-16

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

gullet cancer oesophagus cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Age range

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results