Condition category
Not Applicable
Date applied
14/01/2013
Date assigned
23/01/2013
Last edited
12/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The number of colonoscopies as screening procedures has increased in recent years and will continue to so in the near future. Patients undergoing such procedures expect safe and comfortable environments. It is not surprising that the number of patients and endoscopists' requests for sedation has also increased.
The aim of our study is to investigate the differences in patient and endoscopist's level of satisfaction and experience and how safe the different sedation methods are.

Who can participate?
Patients undergoing elective diagnostic or therapeutic colonoscopy, over 18 years old.

What does the study involve?
Patients will randomly allocated to three groups for three commonly used sedations. Group 1 will receive sedation with midazolam/fentanyl by gastroenterologist, Group 2 will receive sedation with propofol TCI/ alfentanil by anaesthesia nurse, and Group 3 will receive alfentanil by gastroenterologist. All patients will fill in a questionnaire before and after the procedure. Endoscopists will also have to fill in a questionnaire. Patients will also have to perform the Trieger dot test (combine points with a pen). Patients in all three groups will be monitored in the standard way and will receive a face mask with 2l of oxygen from start of sedation till the end of the endoscopic procedure. Interventions will be monitored using a video assisted camera system. In the recovery room patients will be monitored and will stay for 1 hour. The following day there will a phone interview with another questionnaire about satisfaction.

What are the possible benefits and risks of participating?
The benefits include: answers to as to which form of sedation is most satisfying and safe for patients and improved sedation management for future patients. There are no additional risks of participating.

Where is the study run from?
Academic Medical Centre (AMC), Amsterdam, the Netherlands

When is the study starting and how long is it expected to run for?
The study ran from October 2010 to March 2011.

Who is funding the study?
Internal funding AMC

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

Additional identifiers

EudraCT number

2010-020502-15

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Patient And Gastroenterologists Experience with different sedation regimes during colonoscopies

Acronym

PAGE

Study hypothesis

Opioid only sedation with Alfentanil is as safe as other sedation regimes and results in satisfied patients.

Ethics approval

Medical Ethical Committee Academic Medical Center [Medisch Ethische Toetsingscommissie Academisch Medisch Centrum], 17/06/2010, ref: METC 10/060, NL31863

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

Condition

Elective colonoscopies for diagnostic or therapeutical interventions

Intervention

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 accomplished propofol/alfentanil sedation.

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 midazolam/fentanyl by gastroenterologist to achieve the targeted sedation score (Observer/Assessment of Alertness/Sedation Scale >=4 ).

Group 2 will receive sedation with propofol TCI/ alfentanil by anaesthesia nurse to achieve the targeted sedation score (Observer Assessment of Alertness/Sedation OAAS Scale>=4).

Group 3 will receive alfentanil by gastroenterologist to achieve the targeted sedation score (OAAS Scale>=4 ).

Patients in all three groups will be monitored using SO2, Electrocardiography (ECG), Non-invasive measurement of blood pressure (NIBP) and capnography, reflecting common practice. All patients will receive a face mask with 2 litre of oxygen from start of sedation till the end of the endoscopic procedure.

Interventions will be monitored using a video assisted camera system, which will not only provide an overview over the hole situation (patient, nurse, endoscopist), but also register time adapted SO2, ECG, NIBP and capnography.

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 1 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

Alfentanil, fentanyl, midazolam, propofol

Primary outcome measures

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 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).

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)

Overall trial start date

01/10/2010

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant 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

Recruitment start date

01/10/2010

Recruitment end date

01/04/2011

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

Sponsor type

Hospital/treatment centre

Website

http://www.amc.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24973875

Publication citations

Additional files

Editorial Notes