Patient and gastroenterologists experience with different sedation regimes during colonoscopies (PAGE)

Patient and gastroenterologists experience with different sedation regimes during colonoscopies (PAGE) - Patient and gastroenterologists experience with sedation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34691

Enrollment

180

Registered

2010-05-21

Start date

2010-06-01

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

darmstelselaandoeningen bowel endoscopy colonoscopie

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Eligible patients for participation in this clinical trial are those planned to undergo elective diagnostic or therapeutic colonoscopy. 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 * IV. Written informed consent.

Exclusion criteria

Exclusion criteria: Age range

Design outcomes

Primary

Measure	Time frame
Main study parameters are the experiences (e.g. satisfaction levels reached) made by patients and gastroenterologist during sedation. These parameters are collected by means of questionnaires before and after the procedure and on the following day. We will also measure heart rate and heart rate variability by Holter ECG as a mark for gastroenterologist stress level during colonoscopy (stress level of an anesthesiologist can not be measured as there is normally no anesthesiologist during these diagnostic procedures). Further study parameters include in patients measurement of oxygen saturation (SO2) measured by pulseoxymetry, exhaled CO2 (capnography), heart rate, arrhythmias (ECG) and blood pressure (non-invasive blood pressure measurement, NIBP). These parameters are surrogate parameters of pulmonary and cardiovascular problems, experienced by the patient during sedation.	—

Measure

Time frame

Main study parameters are the experiences (e.g. satisfaction levels reached) made by patients and gastroenterologist during sedation. These parameters are collected by means of questionnaires before and after the procedure and on the following day. We will also measure heart rate and heart rate variability by Holter ECG as a mark for gastroenterologist stress level during colonoscopy (stress level of an anesthesiologist can not be measured as there is normally no anesthesiologist during these diagnostic procedures). Further study parameters include in patients measurement of oxygen saturation (SO2) measured by pulseoxymetry, exhaled CO2 (capnography), heart rate, arrhythmias (ECG) and blood pressure (non-invasive blood pressure measurement, NIBP). These parameters are surrogate parameters of pulmonary and cardiovascular problems, experienced by the patient during sedation.

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Countries

Netherlands

Outcome results