The aim of the present study is to investigate the differences in patient and endoscopist satisfaction and experiences and patient*s safety with different sedation protocols.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
darmstelselaandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
not applicable
Background summary
The number of endoscopic gastroenterological procedures tremendously increased
in recent years and will further rise in the near future. In our study we will
focus on colonoscopies.
Patients undergoing such interventions expect a safe and in particular
comfortable manner of riding out those routines. It is thus not surprising that
the demand for sedation during endoscopic procedures by the patient and the
endoscopist has increased nowadays.
This trial focuses on patient and gastroenterologist satisfaction and patient
safety. The study thereby will be performed comparing three commonly used
strategies for sedation: alfentanil * given by endoscopist - will be compared
with fentanyl/midazolam based sedation by gastroenterologist and anesthesia
nurse accomplished propofol/alfentanil sedation.
Study objective
The aim of the present study is to investigate the differences in patient and
endoscopist satisfaction and experiences and patient*s safety with different
sedation protocols.
Study design
Study will be performed as a randomized controlled trial.
Intervention
not applicable
Study burden and risks
Measurements which were taken during colonoscopy reflecting common clinical
practice. Patients and gastroenterologists have to fill in questionnaires
before and after the intervention.
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-020502-15-NL |
| CCMO | NL31863.018.10 |