Inflammatory Bowel DiseasePhase 4NCT01934088
Satisfaction With Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl Sedation for Endoscopy
A Phase 4 study testing Propofol, Midazolam and Fentanyl in people with Inflammatory Bowel Disease and Endoscopy, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
Sedation for endoscopy is a service more than a necessity. Therefore it should be patient driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic control. Therefore, satisfaction with the procedure experience is paramount for patients with IBD. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inflammatory Bowel Disease, Endoscopy, Sedation
- What is being tested?
- Propofol, Midazolam and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inflammatory Bowel Disease (IBD) or suspected IBD
- Planned Endoscopy
- Candidate for propofol sedation
- willingness to be randomized
- Ability to complete questionnaire
Who cannot join
- Allergy to drugs
- American Society of Anesthesiologists Class III
- Body Mass Index > 35
- Ventricular retention
- Acute condition
- Severe Chronic obstructive pulmonary disease
Show all 10Show fewer
- Sleep apnea
- Potentially difficult airway or previous difficulty with anesthesia
- Pregnancy
- <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse Administered Propofol Sedation vs. Standard Therapy for Colonoscopy in Patients With IBD. A Randomised Controlled Study on Satisfaction and Adherence to Treatment Program.
Sedation for endoscopy is a service more than a necessity. Therefore it should be patient driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic control. Therefore, satisfaction with the procedure experience is paramount for patients with IBD. Investigators wish to study the feasibility and the effect on patient experience of two drugs. Propofol administered by endoscopy nurses (NAPS) and conventional therapy with a combination of fentanyl and midazolam. Investigators hypothesize that patients sedated with propofol has a better procedure experience, that a well performed sedation equals a better experience and that NAPS is as feasible as fentanyl with midazolam sedation.
- Conditions
- Inflammatory Bowel Disease, Endoscopy, Sedation
- Keywords
- Inflammatory Bowel disease, IBD, Sedation, NAPS, Propofol, Midazolam, Satisfaction, Feasibility
- Medical subject headings
- Inflammatory Bowel Diseases, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
MidazolamDrug
Also called Midazolam "Hameln" ATC-code: N05CD08
FentanylDrug
Also called Fentanyl "Hameln" ATC-code: N01AH01
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | Propofol in refract doses. Induction: 10-60 mg supplemented with 10-30 mg following an age correlated algorithm. Maintenance with refract bolus of 10-20 mg every 1-2 minutes after assessed need and condition Receives: Drug: Propofol |
| Fentanyl and Midazolam | Active comparator | 0.025-0.05 mg of Fentanyl i.v. minimum 5 minutes before procedure as a single shot. Midazolam 1-2 mg i.v. for induction and 0.5-1 mg i.v. for maintenance after assessing needs and condition Receives: Drug: Midazolam; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction
Satisfaction points in a post procedure questionnaire.
Measured: Participants will be interviewed when an Aldrete recovery score of 12 is achieved, an expected average of 2 hours after admission
Secondary outcomes (1)
Pre-disposing factors for satisfaction with procedure and sedation
pre-operative questionnaire
Measured: At admission to the hospital at time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeppe Thue Jensen, Copenhagen University Hospital at Herlev
- Investigators
- Jeppe Thue Jensen, MD, Principal investigator, Gastroenheden D, endoscopy, Herlev HospitalPeter Vilmann, Professor, Study director, Gastroenheden D, Endoscopy, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934088
- Sponsor's protocol ID
- 2013052044 v.1
- Status last verified
- Sep 2015
- First submitted
- 12 Aug 2013
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen JT, Vilmann P, Horsted T, Hornslet P, Bodtger U, Banning A, Hammering A. Nurse-administered propofol sedation for endoscopy: a risk analysis during an implementation phase. Endoscopy. 2011 Aug;43(8):716-22. doi: 10.1055/s-0030-1256515. Epub 2011 Aug 2.
PubMed 21811940Steenholdt C, Jensen JT, Brynskov J, Moller AM, Limschou AC, Konge L, Vilmann P. Patient Satisfaction of Propofol Versus Midazolam and Fentanyl Sedation During Colonoscopy in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2022 Mar;20(3):559-568.e5. doi: 10.1016/j.cgh.2020.10.037. Epub 2020 Oct 22.
PubMed 33371995
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Administered Propofol Sedation vs. Standard Therapy for Colonoscopy in Patients With IBD. A Randomised Controlled Study on Satisfaction and Adherence to Treatment Program.
- ClinicalTrials.gov ID
- NCT01934088
- Acronym / sponsor ID
- 2013052044 v.1
- Conditions
- Inflammatory Bowel Disease, Endoscopy, Sedation
- Keywords
- Inflammatory Bowel disease, IBD, Sedation, NAPS, Propofol, Midazolam, Satisfaction, Feasibility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sedation for endoscopy is a service more than a necessity. Therefore it should be patient driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic control. Therefore, satisfaction with the procedure experience is paramount for patients with IBD. Investigators wish to study the feasibility and the effect on patient experience of two drugs. Propofol administered by endoscopy nurses (NAPS) and conventional therapy with a combination of fentanyl and midazolam. Investigators hypothesize that patients sedated with propofol has a better procedure experience, that a well performed sedation equals a better experience and that NAPS is as feasible as fentanyl with midazolam sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: PropofolPropofol in refract doses. Induction: 10-60 mg supplemented with 10-30 mg following an age correlated algorithm. Maintenance with refract bolus of 10-20 mg every 1-2 minutes after assessed need and condition |
| Fentanyl and Midazolam | Active comparator | Drug: Midazolam, Drug: Fentanyl0.025-0.05 mg of Fentanyl i.v. minimum 5 minutes before procedure as a single shot. Midazolam 1-2 mg i.v. for induction and 0.5-1 mg i.v. for maintenance after assessing needs and condition |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inflammatory Bowel Disease (IBD) or suspected IBD
- Planned Endoscopy
- Candidate for propofol sedation
- willingness to be randomized
- Ability to complete questionnaire
Key exclusion criteria (10 listed)
- Allergy to drugs
- American Society of Anesthesiologists Class III
- Body Mass Index > 35
- Ventricular retention
- Acute condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol | Drug | Propofol |
| MidazolamAlso: Midazolam "Hameln" ATC-code: N05CD08 | Drug | Fentanyl and Midazolam |
| FentanylAlso: Fentanyl "Hameln" ATC-code: N01AH01 | Drug | Fentanyl and Midazolam |
Primary outcome
Satisfaction
Time frame: Participants will be interviewed when an Aldrete recovery score of 12 is achieved, an expected average of 2 hours after admission
Satisfaction points in a post procedure questionnaire.
1 secondary outcome
Pre-disposing factors for satisfaction with procedure and sedation
Time frame: At admission to the hospital at time 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
- Background: PubMed 21811940Jensen JT, Vilmann P, Horsted T, Hornslet P, Bodtger U, Banning A, Hammering A. Nurse-administered propofol sedation for endoscopy: a risk analysis during an implementation phase. Endoscopy. 2011 Aug;43(8):716-22. doi: 10.1055/s-0030-1256515. Epub 2011 Aug 2.
- Derived from this study: PubMed 33371995Steenholdt C, Jensen JT, Brynskov J, Moller AM, Limschou AC, Konge L, Vilmann P. Patient Satisfaction of Propofol Versus Midazolam and Fentanyl Sedation During Colonoscopy in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2022 Mar;20(3):559-568.e5. doi: 10.1016/j.cgh.2020.10.037. Epub 2020 Oct 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeppe Thue Jensen, MD principal investigator
Gastroenheden D, endoscopy, Herlev Hospital
Peter Vilmann, Professor study director
Gastroenheden D, Endoscopy, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol, Midazolam and Fentanyl in people with Inflammatory Bowel Disease and Endoscopy, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction (time frame: Participants will be interviewed when an Aldrete recovery score of 12 is achieved, an expected average of 2 hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01934088, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2015.