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

Conditions: darmstelselaandoeningen
bowel endoscopy
colonoscopie

Registration Number: NL-OMON34691

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 180

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

Age range < 18 years
ASA classification V
Allergic reaction to planned medication in the patients* medical history
Unregulated hypertension
Bradycardia, arrhythmia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures