Patient And Gastroenterologists Experience with sedation during colonoscopies

Patient And Gastroenterologists Experience with different sedation regimes during colonoscopies

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN83950185

Enrollment

180

Registered

2013-01-23

Start date

2010-10-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Elective colonoscopies for diagnostic or therapeutical interventions Not Applicable

Interventions

The study compares three commonly used strategies for sedation: alfentanil given by endoscopist - will be compared with fentanyl/midazolam based sedation by gastroenterologist and anaesthesia nurse a

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
to clarify whether there are differences in experience and satisfaction of patients and endoscopists between different clinically used sedation regimes in patients undergoing colonoscopy? 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.	—

Measure

Time frame

to clarify whether there are differences in experience and satisfaction of patients and endoscopists between different clinically used sedation regimes in patients undergoing colonoscopy? 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

Measure	Time frame
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). Pre procedure Patient (part 1) and endoscopist: questionnaire Patient: Trieger Test Colonoscopy procedure: Sedation regime 1, 2, or 3 Monitoring using SO2, ECG, NIBP, capnography Face mask with 2 l O2 Recovery room (post procedure): Aldrete score (30, 60 min) 30 min Patient (part 2a) and endoscopist questionnaire Patient: Trieger Test 60 min Patient: Trieger Test Next day: Interview with patient by phone (part 2 c questionnaire)	—

Measure

Time frame

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). Pre procedure Patient (part 1) and endoscopist: questionnaire Patient: Trieger Test Colonoscopy procedure: Sedation regime 1, 2, or 3 Monitoring using SO2, ECG, NIBP, capnography Face mask with 2 l O2 Recovery room (post procedure): Aldrete score (30, 60 min) 30 min Patient (part 2a) and endoscopist questionnaire Patient: Trieger Test 60 min Patient: Trieger Test Next day: Interview with patient by phone (part 2 c questionnaire)

—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026