Digestive System DiseasesNCT02067065
Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial
A study testing Non-anesthesiologist propofol sedation, Propofol sedation administered by an anesthesiologist and Colonoscopy in people with Digestive System Diseases and Colonoscopy Sedation, run by Hospital Beatriz Ângelo at 1 site in Portugal.
Trial summary
Propofol is the preferred sedation for colonoscopy. There is debate on the safety of the administration of propofol by non-anesthesiologists, despite moderate quality evidence that support its' use. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Digestive System Diseases, Colonoscopy Sedation
- What is being tested?
- Non-anesthesiologist propofol sedation, Propofol sedation administered by an anesthesiologist and Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2014to Aug 2015
- Phase
- Interventional
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Referred for elective colonoscopy as outpatients
- Must be able to provide the informed consent
Who cannot join
- American Society of Anaesthesiologists (ASA) class >2
- Pregnant women
- Difficult airway predictors (more than 2 ou Mallampati >3)
- Allergy to propofol or its' components
- IV drugs abuse
Trial locations and contacts
1 site in 1 country.
About this study
Propofol is the preferred sedation for colonoscopy. There is debate on the safety of the administration of propofol by non-anesthesiologists, despite moderate quality evidence that support its' use.
There is only one small trial of a direct comparison of propofol sedation by anesthesiologists versus non-anesthesiologists.
Read more
Our aim is to compare the incidence of sedation related adverse events, the procedural quality indicators, times (onset, recovery, discharge) and patient satisfaction between non-anesthesiologist administered propofol sedation (NAAP) sedation and anesthesiologist propofol sedation.
A randomized clinical trial with the incidence of sedation related minor adverse events as primary endpoint will be conducted. Secondary endpoints include procedure quality indicators, propofol dosage and patient satisfaction.
A sample size of 330 subjects (2 arms of 165 patients) will be needed in order to obtain 90% power and a 5% significance level to exclude a 15% difference (15 - 30%) in adverse events incidence, estimated from our pilot experience. The sample size was adjusted for a 2% cross-over rate.
Informed and consenting patients undergoing colonoscopy examinations will be randomly assigned to one of two arms. One group will be sedated by an anesthesiologist according to a protocol of propofol mono-sedation. The other group will be sedated with propofol boluses, according to the European Society of Gastrointestinal Endoscopy (ESGE) NAAP guideline, with a 3-man team consisting of one endoscopist, one endoscopy nurse and a sedation nurse, trained in NAAP and exclusively dedicated to sedation and patient monitoring.
- Conditions
- Digestive System Diseases, Colonoscopy Sedation
- Being tested
- Non-anesthesiologist propofol sedation, Propofol sedation administered by an anesthesiologist, Colonoscopy
- Keywords
- Colonoscopy, Sedation, Propofol, Non-anesthesiologist propofol administration
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-anesthesiologist propofol sedationDrug
Bolus propofol sedation administered according to non-anesthesiologist propofol sedation guidelines of the European Society of Gastrointestinal Endoscopy
Propofol sedation administered by an anesthesiologistDrug
Propofol sedation by an anesthesiologist
ColonoscopyProcedure or surgery
Elective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated
| Study group | Role | What they receive |
|---|---|---|
| Non-anesthesiologist propofol sedation | Experimental | Bolus propofol sedation by non-anesthesiologist Receives: Drug: Non-anesthesiologist propofol sedation; Procedure: Colonoscopy |
| Anesthesiologist administered propofol | Active comparator | Propofol sedation administered by an anesthesiologist Receives: Drug: Propofol sedation administered by an anesthesiologist; Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minor adverse events
Minor adverse events as defined by the International Sedation Task Force, including peripheral O2 saturation between 75-90% for less than 60 seconds, apnea, airway obstruction, sedation failure, allergic reaction without anaphylaxis, convulsion, brady/tachycardia and hypo/hypertension (>25% change from baseline)
Measured: During the sedation period
Secondary outcomes (4)
Propofol dosage
Total propofol dosage
Measured: During the colonoscopy - an estimated mean time of 20 minutes
Patient satisfaction
A 10 point visual scale on pain
Measured: Before discharge - estimated mean recovery time of 1 hour
colonoscopy quality indicators
Colonoscopy quality indicators: time to cecum, withdrawal time, adenoma detection rate
Measured: During the procedure
Patient satisfaction 2
A 5 point likert scale on patient satisfaction with the sedation
Measured: Before discharge - estimated mean recovery time of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Digestive System DiseasesStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Beatriz Ângelo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Ferreira, Hospital Beatriz Ângelo
- Investigators
- Alexandre O Ferreira, MD, Principal investigator, Hospital Beatriz Ângelo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067065
- Sponsor's protocol ID
- ColonPropo-01
- Status last verified
- Oct 2015
- First submitted
- 16 Feb 2014
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11.
PubMed 21072716Dumonceau JM, Riphaus A, Beilenhoff U, Vilmann P, Hornslet P, Aparicio JR, Dinis-Ribeiro M, Giostra E, Ortmann M, Knape JT, Ladas S, Paspatis G, Ponsioen CY, Racz I, Wehrmann T, Walder B. European curriculum for sedation training in gastrointestinal endoscopy: position statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA). Endoscopy. 2013 Jun;45(6):496-504. doi: 10.1055/s-0033-1344142. Epub 2013 May 23. No abstract available.
PubMed 23702777Ferreira AO, Torres J, Barjas E, Nunes J, Gloria L, Ferreira R, Rocha M, Pereira S, Dias S, Santos AA, Cravo M. Non-anesthesiologist administration of propofol sedation for colonoscopy is safe in low risk patients: results of a noninferiority randomized controlled trial. Endoscopy. 2016 Aug;48(8):747-53. doi: 10.1055/s-0042-105560. Epub 2016 Apr 21.
PubMed 27100716
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02067065
- Acronym / sponsor ID
- ColonPropo-01
- Conditions
- Digestive System Diseases, Colonoscopy Sedation
- Keywords
- Colonoscopy, Sedation, Propofol, Non-anesthesiologist propofol administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Hospital Beatriz ÂngeloUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Feb 2014 (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.
Propofol is the preferred sedation for colonoscopy. There is debate on the safety of the administration of propofol by non-anesthesiologists, despite moderate quality evidence that support its' use.
There is only one small trial of a direct comparison of propofol sedation by anesthesiologists versus non-anesthesiologists.
Our aim is to compare the incidence of sedation related adverse events, the procedural quality indicators, times (onset, recovery, discharge) and patient satisfaction between non-anesthesiologist administered propofol sedation (NAAP) sedation and anesthesiologist propofol sedation.
A randomized clinical trial with the incidence of sedation related minor adverse events as primary endpoint will be conducted. Secondary endpoints include procedure quality indicators, propofol dosage and patient satisfaction.
A sample size of 330 subjects (2 arms of 165 patients) will be needed in order to obtain 90% power and a 5% significance level to exclude a 15% difference (15 - 30%) in adverse events incidence, estimated from our pilot experience. The sample size was adjusted for a 2% cross-over rate.
Informed and consenting patients undergoing colonoscopy examinations will be randomly assigned to one of two arms. One group will be sedated by an anesthesiologist according to a protocol of propofol mono-sedation. The other group will be sedated with propofol boluses, according to the European Society of Gastrointestinal Endoscopy (ESGE) NAAP guideline, with a 3-man team consisting of one endoscopist, one endoscopy nurse and a sedation nurse, trained in NAAP and exclusively dedicated to sedation and patient monitoring.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-anesthesiologist propofol sedation | Experimental | Drug: Non-anesthesiologist propofol sedation, Procedure: ColonoscopyBolus propofol sedation by non-anesthesiologist |
| Anesthesiologist administered propofol | Active comparator | Drug: Propofol sedation administered by an anesthesiologist, Procedure: ColonoscopyPropofol sedation administered by an anesthesiologist |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Referred for elective colonoscopy as outpatients
- Must be able to provide the informed consent
Key exclusion criteria (5 listed)
- American Society of Anaesthesiologists (ASA) class >2
- Pregnant women
- Difficult airway predictors (more than 2 ou Mallampati >3)
- Allergy to propofol or its' components
- IV drugs abuse
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 |
|---|---|---|
| Non-anesthesiologist propofol sedationBolus propofol sedation administered according to non-anesthesiologist propofol sedation guidelines of the European Society of Gastrointestinal Endoscopy | Drug | Non-anesthesiologist propofol sedation |
| Propofol sedation administered by an anesthesiologistPropofol sedation by an anesthesiologist | Drug | Anesthesiologist administered propofol |
| ColonoscopyElective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated | Procedure or surgery | Anesthesiologist administered propofol, Non-anesthesiologist propofol sedation |
Primary outcome
Minor adverse events
Time frame: During the sedation period
Minor adverse events as defined by the International Sedation Task Force, including peripheral O2 saturation between 75-90% for less than 60 seconds, apnea, airway obstruction, sedation failure, allergic reaction without anaphylaxis, convulsion, brady/tachycardia and hypo/hypertension (>25% change from baseline)
4 secondary outcomes
Propofol dosage
Time frame: During the colonoscopy - an estimated mean time of 20 minutes
Patient satisfaction
Time frame: Before discharge - estimated mean recovery time of 1 hour
colonoscopy quality indicators
Time frame: During the procedure
Patient satisfaction 2
Time frame: Before discharge - estimated mean recovery time of 1 hour
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 12 Oct 2015.
- Background: PubMed 21072716Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11.
- Background: PubMed 23702777Dumonceau JM, Riphaus A, Beilenhoff U, Vilmann P, Hornslet P, Aparicio JR, Dinis-Ribeiro M, Giostra E, Ortmann M, Knape JT, Ladas S, Paspatis G, Ponsioen CY, Racz I, Wehrmann T, Walder B. European curriculum for sedation training in gastrointestinal endoscopy: position statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA). Endoscopy. 2013 Jun;45(6):496-504. doi: 10.1055/s-0033-1344142. Epub 2013 May 23. No abstract available.
- Derived from this study: PubMed 27100716Ferreira AO, Torres J, Barjas E, Nunes J, Gloria L, Ferreira R, Rocha M, Pereira S, Dias S, Santos AA, Cravo M. Non-anesthesiologist administration of propofol sedation for colonoscopy is safe in low risk patients: results of a noninferiority randomized controlled trial. Endoscopy. 2016 Aug;48(8):747-53. doi: 10.1055/s-0042-105560. Epub 2016 Apr 21.
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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.
Alexandre O Ferreira, MD principal investigator
Hospital Beatriz Ângelo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-anesthesiologist propofol sedation, Propofol sedation administered by an anesthesiologist and Colonoscopy in people with Digestive System Diseases and Colonoscopy Sedation, run by Hospital Beatriz Ângelo at 1 site in Portugal.
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 2 inclusion and 5 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 12 Oct 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 Portugal. 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.
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?
Minor adverse events (time frame: During the sedation period). 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 NCT02067065, which also lists 3 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 12 Oct 2015.