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

NCT02067065 | Completed DMC

• 1 other identifier: ColonPropo-01
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Digestive System Diseases; Colonoscopy Sedation

Keywords

Colonoscopy; Sedation; Propofol; Non-anesthesiologist propofol administration

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Propofol dosage

  During the colonoscopy - an estimated mean time of 20 minutes

• Patient satisfaction

  Before discharge - estimated mean recovery time of 1 hour

• colonoscopy quality indicators

  During the procedure

• Patient satisfaction 2

  Before discharge - estimated mean recovery time of 1 hour

Study Arms (2)

Non-anesthesiologist propofol sedation

EXPERIMENTAL

Bolus propofol sedation by non-anesthesiologist

Drug: Non-anesthesiologist propofol sedation; Procedure: Colonoscopy

Anesthesiologist administered propofol

ACTIVE COMPARATOR

Propofol sedation administered by an anesthesiologist

Drug: Propofol sedation administered by an anesthesiologist; Procedure: Colonoscopy

Interventions

Non-anesthesiologist propofol sedation DRUG

Bolus propofol sedation administered according to non-anesthesiologist propofol sedation guidelines of the European Society of Gastrointestinal Endoscopy

Non-anesthesiologist propofol sedation

Propofol sedation administered by an anesthesiologist DRUG

Propofol sedation by an anesthesiologist

Anesthesiologist administered propofol

Colonoscopy PROCEDURE

Elective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated

Anesthesiologist administered propofol; Non-anesthesiologist propofol sedation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred for elective colonoscopy as outpatients
• Must be able to provide the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Beatriz Ângelo: lead

Study Sites (1)

Hospital Beatriz Ângelo

Loures, 2674-514, Portugal

Location

Related Publications (3)

• 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.

  PMID: 21072716 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.

  PMID: 23702777 BACKGROUND

• 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.

  PMID: 27100716 DERIVED

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Alexandre O Ferreira, MD

  Hospital Beatriz Ângelo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 16, 2014
• First Posted: February 20, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

PT (1)