Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol (ADR_NAAP)

Serveis de Salut Integrats Baix Empordà

Status: Completed

Conditions: Colo-rectal Cancer; ADR; Colon Adenoma

Treatments: Procedure: Sedation directed by an endoscopist; Procedure: Sedation directed by an anesthesiologist

Study type: Interventional

Funder types: Other

Identifiers

NCT03922074

42319_TDA_ANE

Details and patient eligibility

About

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).

Enrollment: 630 patients

Sex: All

Ages: 50 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Healthy patients -

Exclusion criteria

Patients with familial colorectal cancer history

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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630 participants in 2 patient groups

Non-anesthesiologist administered propofol

Experimental group

Description:

Sedation directed by an endoscopist in which the intravenous drugs are propofol and fentanyl . Target level sedation: moderate - deep.

Treatment:

Procedure: Sedation directed by an endoscopist

Monitored anesthesia care

Active Comparator group

Description:

Sedation directed by an anesthesiologist in which the used intravenous drugs and target level sedation are chosen by the anesthesiologist.

Treatment:

Procedure: Sedation directed by an anesthesiologist