Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol

Not Applicable

Completed

• Conditions: ADR; Colo-rectal Cancer; Colon Adenoma
• Interventions: Procedure: Sedation directed by an anesthesiologist; Procedure: Sedation directed by an endoscopist

• Registration Number: NCT03922074
• Lead Sponsor: Serveis de Salut Integrats Baix Empordà

Brief Summary

The Efficacy and safety of Non-anesthesiologist administered propofol (NAAP) for gastrointestinal endoscopy have been widely documented although there is not information which has evaluated the outcomes of colonoscopy it self when the endoscopist has to fulfill the additional task of supervising the sedation.

Objective: To determine the equivalence of adenoma detection rate (ADR) in colorectal cancer (CRC) screening colonoscopies performed with NAAP and performed with monitored anesthesia care (MAC).

Method: Single blind non-randomized controlled equivalence trial. Patients: Adults between 50 - 69 years old from National CRC screening program (CRCSP). Intervention: The patients are blindly assigned to undergo either colonoscopy with NAAP or MAC according to the arrival of fecal occult blood test, patient's suitability for colonoscopy date and availability of places at endoscopy schedule (with NAAP or MAC).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-02
• Primary Completion: 2018-12-31
• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-19
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-13
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

Healthy patients -

Exclusion Criteria

Patients with familial colorectal cancer history

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monitored anesthesia care	Sedation directed by an anesthesiologist	Sedation directed by an anesthesiologist in which the used intravenous drugs and target level sedation are chosen by the anesthesiologist.
Non-anesthesiologist administered propofol	Sedation directed by an endoscopist	Sedation directed by an endoscopist in which the intravenous drugs are propofol and fentanyl . Target level sedation: moderate - deep.

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	30 days	Percentage of patients aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected and removed