Patient safety and satisfaction with dexmedetomidine sedation during endoscopic oesophageal interventions
| ISRCTN | ISRCTN68599804 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68599804 |
| EudraCT/CTIS number | 2011-004206-19 |
| Secondary identifying numbers | NL36861.018.11 |
- Submission date
- 03/04/2013
- Registration date
- 16/04/2013
- Last edited
- 08/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Endoscopic treatment of early neoplastic lesions in the oesophagus has become a valid and less invasive alternative than surgical resection. These endoscopic interventions are minimal invasive treatment options usually done with sedation on an outpatient basis. The aim of this study is to determine how well dexmedetomidine sedation works compared to standard propofol/alfentanil sedation during endoscopic oesophageal interventions.
Who can participate?
Patients planned to undergo an elective endoscopic oesophagus intervention.
What does the study involve?
Participants are randomly allocated to one of two groups: Group 1 will receive sedation with propofol TCI/alfentanil by an anaesthesia nurse. Group 2 will receive dexmedetomidine by anaesthesia nurse. All patients will receive a validated questionnaire to fill in before and after the procedure. Additionally, endoscopists have to fill in a validated questionnaire. Patients also have to perform the Trieger dot test (combine points with a pen). The following day there is a phone interview with another questionnaire about satisfaction.
What are the possible benefits and risks of participating?
The study will help answer the question of which form of sedation is most satisfying and safe for patients, and to improve sedation management for future patients. There are no additional risks of participating.
Where is the study run from?
AMC, Amsterdam, the Netherlands
When is the study starting and how long is it expected to run for?
July 2012 to August 2013
Who is funding the study?
AMC, Amsterdam, the Netherlands
Who is the main contact?
Prof Dr. Dr. M.W. Hollmann
M.W.Hollmann@amc.uva.nl
Contact information
Scientific
Academic Medical Centre, University of Amsterdam, Meibergdreef 9
Amsterdam
1100DD
Netherlands
Amsterdam
1100DD
Netherlands
| Phone | +31 (0)20 5669111 |
|---|---|
| M.W.Hollmann@amc.uva.nl |
Study information
| Study design | Single-center randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet' |
| Scientific title | Safety and Effectiveness using DEXmedetomidine sedation versus propofol/alfentanil sedation during oesophagus interventions |
| Study acronym | SEDEX |
| Study objectives | Dexmedetomidine sedation is as safe as the standard sedation regime and results in satisfied patients. |
| Ethics approval(s) | Medisch Ethische Toetsingscommissie Academisch Medisch Centrum, 12/01/2012, NL36861.018.11 |
| Health condition(s) or problem(s) studied | Elective endoscopic oesophageal interventions |
| Intervention | The study compares two strategies for sedation: Dexmedetomidine based sedation will be compared with propofol/alfentanil sedation both accomplished by an anaesthesia nurse. All patients will receive a validated questionnaire to fill in before procedure and perform the Trieger test as a measure of psychomotoric recovery from sedation. Additionally, endoscopists have to fill in a validated questionnaire. Group 1 will receive sedation with propofol Target Controlled Infusion (TCI)/ alfentanil (100 µg) and group 2 with dexmedetomidine both supplied by an anesthesia nurse to achieve the targeted sedation score (Observers Assessment of Alertness/Sedation OAAS Scale < 4), which means the patients maximal lethargic response to their name spoken in normal tone. Patients in all three groups will be monitored using SO2, ECG, NIBP and capnography, non invasive cardiac output and sweat production/conduction. All patients will receive a face mask with 2l of oxygen from start of sedation till the end of the endoscopic procedure. At arrival in the recovery room patients will be monitored by pulse oximetry (SO2), ECG and NIBP only. All patients will stay in the recovery room for 2 hours. At arrival, 30 and 60 min later virtual discharge will be determined based on Aldrete Score. Ready for discharge will be declared when an Aldrete Score of nine (9) or pre-procedure score is met. The next day the patient is called at home to answer part 2 of the questionnaire. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dexmedetomidine, Propofol, Alfentanil |
| Primary outcome measure | 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) and non- invasive cardiac output measurement. |
| Secondary outcome measures | How is the effectiveness of dexmedetomidine compared with propofol/alfentanil during oesophagus interventions? Surrogate parameters of effectiveness are satisfaction levels, pain score, sedation score (questionnaire for patients and gastroenterologists). |
| Overall study start date | 16/07/2012 |
| Completion date | 01/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 64 |
| Key inclusion criteria | Eligible patients for participation in this clinical trial are those planned to undergo elective endoscopic oesophagus intervention. The patients must comply with the following criteria in order to be eligible to participate in this clinical study: 1. Male and female, age range ≥ 18 years without upper age limit 2. ASA classification I III 3. Written informed consent |
| Key exclusion criteria | 1. Age range < 18 years 2. ASA classification IV and V 3. Allergic reaction to planned medication in the patients medical history 4. Unregulated hypertension 5. Hypovolemia or hypotension (systolic blood pressure <80 or mean arterial pressure <50 mmHg) 6. Severe bradycardia (heart rate < 50/min) and / or related brady-dysrhythmias (e.g. advanced heart block) 7. Impaired ventricular function (left ventricular ejection fraction <30%) 8. Impaired renal function, GFR less than 15ml/min or undergoing hemodialysis 9. Impaired liver function 10. Substance abuse |
| Date of first enrolment | 16/07/2012 |
| Date of final enrolment | 01/08/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1100DD
Netherlands
Sponsor information
Hospital/treatment centre
Meibergdreef 9
Amsterdam
1100DD
Netherlands
Amsterdam
1100DD
Netherlands
| Phone | +31 (0)20 5669111 |
|---|---|
| M.W.Hollmann@amc.uva.nl | |
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/12/2013 | Yes | No | |
| Results article | results | 01/09/2016 | Yes | No |
Editorial Notes
08/03/2016: Publication reference added.
