Patient And Gastroenterologists Experience with sedation during colonoscopies

Not Applicable

Completed

Conditions: Elective colonoscopies for diagnostic or therapeutical interventions
Not Applicable

Registration Number: ISRCTN83950185

Lead Sponsor: Academic Medical Centre (AMC) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 180

Inclusion Criteria

The patients must comply with the following criteria in order to be eligible to participate in this clinical study:
1. Age range > 18 years without upper limit, female/male
2. American Society of Anesthesiologists (ASA) classification I - IV
3. Patients, undergoing elective diagnostic or therapeutic colonoscopy.
4. Written informed consent

Exclusion Criteria

1. Age range < 18 years
2. ASA classification V
3. Allergic reaction to planned medication in the patient's medical history
4. Unregulated hypertension
5. Bradycardia
6. Arrhythmia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to clarify whether there are differences in experience and satisfaction of patients and endoscopists between different clinically used sedation regimes in patients undergoing colonoscopy? <br><br>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.

Secondary Outcome Measures

Name	Time	Method
Which form of sedation is safer for the patient in regard to respiratory and cardiovascular problems? Surrogate parameters of pulmonary and cardiovascular problems are oxygen saturation (SO2) measured by pulse oximetry, exhaled CO2 (capnography), heart rate, arrhythmias (ECG) and blood pressure (non-invasive blood pressure measurement (NIBP).<br><br>Pre procedure<br>Patient (part 1) and endoscopist: questionnaire<br>Patient: Trieger Test<br><br>Colonoscopy procedure:<br>Sedation regime 1, 2, or 3<br>Monitoring using SO2, ECG, NIBP, capnography<br>Face mask with 2 l O2<br><br>Recovery room (post procedure):<br>Aldrete score (30, 60 min)<br>30 min <br>Patient (part 2a) and endoscopist questionnaire<br>Patient: Trieger Test<br>60 min<br>Patient: Trieger Test<br><br>Next day:<br>Interview with patient by phone (part 2 c questionnaire)