The aim of this study is to determine the patients* and endoscopists experiences and patients* safety with different sedation protocols.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters, reflecting the safety aspect, are measurement of oxygen
saturation (SO2) measured by pulse oximetry, exhaled CO2 (capnography), heart
rate, arrhythmias (ECG) and blood pressure (non-invasive blood pressure
measurement, NIBP) and non-invasive cardiac output monitoring (Nexfin). These
hemodynamic parameters are surrogate parameters of pulmonary and cardiovascular
problems, experienced by the patient during sedation.
Further study parameters measure the effectiveness of the reached sedation
level. These parameters are collected by means of questionnaires before and
after the procedure and on the following day. We will also measure sweat
conductance as a indicator for patients stress level during the procedure.
.
Secondary outcome
not applicable
Background summary
Barrett*s oesophagus develops as a consequence of chronic gastro-oesophageal
reflux disease. It is characterized by abnormal changes in the oesophageal
lining that may, in some patients, become dysplastic and lead to oesophageal
cancer. Oesophagectomy is the standard treatment for high-grade dysplastic
Barrett*s oesophagus or intramucosal cancer; however, it is associated with
significant mortality and morbidity. Consequently less invasive surgical
techniques, such as endoscopic mucosal resection (EMR) and ablative treatments
have been developed and are being used as alternatives for patients who are
unsuitable for surgery or who express a preference for less invasive options.
However these procedures are long lasting, uncomfortable and stressful for most
patients. Furthermore they require patients who are sedated, but easily
arousable to provide excellent view to the oesophagus. Conscious sedation is a
strategy for improving patient comfort during these procedures. In particular,
benzodiazepines and propofol are known to provide excellent sedation. However,
this method is often associated with respiratory depression. 50% of the
morbidity and 60% of the mortality in upper GI endoscopy are related to
sedation-induced hypoxemia. Therefore, other pharmacological agents that induce
an adequate level of sedation without respiratory depression are of increasing
interest to clinicians. Dexmedetomidine, a selective alpha2 adrenoceptor
agonist, as a single agent produces sedation, pain relief, anxiety reduction,
stable respiratory rates, and predictable cardiovascular responses. This
profile has recently gained increased popularity for procedural sedation.
Study objective
The aim of this study is to determine the patients* and endoscopists
experiences and patients* safety with different sedation protocols.
Study design
Study will be performed as a randomized controlled trial.
Intervention
not applicable
Study burden and risks
Measurements were taken during endoscopy and reflect common clinical practice.
Patients and gastroenterologists have to fill in questionnaires before and
after the intervention.
Meibergdreef 9
1100DD Amsterdam
NL
Meibergdreef 9
1100DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Age range * 18 years
ASA classification I * III
Patients, undergoing elective oesophagus intervention
Written informed consent
Exclusion criteria
Age range < 18 years
ASA classification IV and V
Allergic reaction to planned medication in the patients* medical history
Unregulated hypertension
Hypovolemia or hypotension (SBP <80 or MAP <50)
Sever bradycardia (rate < 50) and / or related bradydysrhymias (e.g. advanced heart block)
Impaired ventricular functions (EF <30%)
GFR less than 15ml/min or undergoing hemodialysis
End stage liver disease
Substance abuse
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 | EUCTR2011-004206-19-NL |
| CCMO | NL36861.018.11 |