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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-anesthesiologist propofol sedation | Experimental | Bolus propofol sedation by non-anesthesiologist |
|
| Anesthesiologist administered propofol | Active Comparator | Propofol sedation administered by an anesthesiologist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-anesthesiologist propofol sedation | Drug | Bolus propofol sedation administered according to non-anesthesiologist propofol sedation guidelines of the European Society of Gastrointestinal Endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | During the sedation period |
| Measure | Description | Time Frame |
|---|---|---|
| Propofol dosage | Total propofol dosage | During the colonoscopy - an estimated mean time of 20 minutes |
| Patient satisfaction | A 10 point visual scale on pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre O Ferreira, MD | Hospital Beatriz Ângelo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Beatriz Ângelo | Loures | 2674-514 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21072716 | Background | 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. | |
| 23702777 |
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| Propofol sedation administered by an anesthesiologist | Drug | Propofol sedation by an anesthesiologist |
|
| Colonoscopy | Procedure | Elective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated |
|
| Before discharge - estimated mean recovery time of 1 hour |
| colonoscopy quality indicators | Colonoscopy quality indicators: time to cecum, withdrawal time, adenoma detection rate | During the procedure |
| Patient satisfaction 2 | A 5 point likert scale on patient satisfaction with the sedation | Before discharge - estimated mean recovery time of 1 hour |
| Background |
| Dumonceau 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. |
| 27100716 | Derived | Ferreira 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. |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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