Condition category
Surgery
Date applied
03/04/2013
Date assigned
16/04/2013
Last edited
08/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Markus Hollmann

ORCID ID

Contact details

Academic Medical Centre
University of Amsterdam
Meibergdreef 9
Amsterdam
1100DD
Netherlands
Amsterdam
1100DD
Netherlands
+31 (0)20 5669111
M.W.Hollmann@amc.uva.nl

Additional identifiers

EudraCT number

2011-004206-19

ClinicalTrials.gov number

Protocol/serial number

NL36861.018.11

Study information

Scientific title

Safety and Effectiveness using DEXmedetomidine sedation versus propofol/alfentanil sedation during oesophagus interventions

Acronym

SEDEX

Study hypothesis

Dexmedetomidine sedation is as safe as the standard sedation regime and results in satisfied patients.

Ethics approval

Medisch Ethische Toetsingscommissie Academisch Medisch Centrum, 12/01/2012, NL36861.018.11

Study design

Single-center randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet'

Condition

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 (Observer’s 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

Phase

Not Applicable

Drug names

Dexmedetomidine, Propofol, Alfentanil

Primary outcome measures

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 trial start date

16/07/2012

Overall trial end date

01/08/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

64

Participant 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

Recruitment start date

16/07/2012

Recruitment end date

01/08/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1100DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1100DD
Netherlands
Amsterdam
1100DD
Netherlands
+31 (0)20 5669111
M.W.Hollmann@amc.uva.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Academisch Medisch Centrum

Alternative name(s)

Academic Medical Center, AMC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24377675
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26950082

Publication citations

  1. Protocol

    Eberl S, Preckel B, Bergman JJ, Hollmann MW, Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial., BMC Gastroenterol, 2013, 13, 176, doi: 10.1186/1471-230X-13-176.

  2. Results

    Eberl S, Preckel B, Bergman JJ, van Dieren S, Hollmann MW, Satisfaction and safety using dexmedetomidine or propofol sedation during endoscopic oesophageal procedures: A randomised controlled trial, Eur J Anaesthesiol, 2016 .

Additional files

Editorial Notes

08/03/2016: Publication reference added.