Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial

Digestive System Diseases Clinical Trial

Official title:

Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067065
• Other study ID #: ColonPropo-01
• Status: Completed
• Phase: N/A
• First received: February 16, 2014
• Last updated: October 8, 2015
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Hospital Beatriz Ângelo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Data Protection Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: August 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Referred for elective colonoscopy as outpatients

• Must be able to provide the informed consent

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colonoscopy Sedation
• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Drug:
• Non-anesthesiologist propofol sedation
Bolus propofol sedation administered according to non-anesthesiologist propofol sedation guidelines of the European Society of Gastrointestinal Endoscopy
• Propofol sedation administered by an anesthesiologist
Propofol sedation by an anesthesiologist

Procedure:
• Colonoscopy
Elective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated

Locations

Country	Name	City	State
Portugal	Hospital Beatriz Ângelo	Loures

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Beatriz Ângelo

Country where clinical trial is conducted

Portugal, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Propofol dosage	Total propofol dosage	During the colonoscopy - an estimated mean time of 20 minutes	No
Secondary	Patient satisfaction	A 10 point visual scale on pain	Before discharge - estimated mean recovery time of 1 hour	No
Secondary	colonoscopy quality indicators	Colonoscopy quality indicators: time to cecum, withdrawal time, adenoma detection rate	During the procedure	No
Secondary	Patient satisfaction 2	A 5 point likert scale on patient satisfaction with the sedation	Before discharge - estimated mean recovery time of 1 hour	No