Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol

Study Overview
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Brief Summary
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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).

Official Title
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Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol. An Equivalence Trial

Conditions
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ADR, Colo-rectal Cancer, Colon Adenoma

Intervention / Treatment
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* Procedure: Sedation directed by an endoscopist
* Procedure: Sedation directed by an anesthesiologist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy patients - Exclusion Criteria: Patients with familial colorectal cancer history -

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-anesthesiologist administered propofol<br>Sedation directed by an endoscopist in which the intravenous drugs are propofol and fentanyl . Target level sedation: moderate - deep. | Procedure: Sedation directed by an endoscopist<br>* The nurse begins with fentanyl infusion in bolus: 75 μg (1.5 ml) and initial propofol dose (10mg/ml) in bolus of 0.5 - 2.5 mg/Kg followed by a maintenance dose of 20 - 60ml/h through Target-controlled infusion (TCI) pump. In this way, we get a target level sedation between 1 - 3, according to Observer's Assessment of Alertness/Sedation Scale (OAAS). The role of the nurse, directed by an endoscopist, it is exclusively the administration of intravenous drugs and the patient monitorship throughout the procedure.<br>|
| Active Comparator: Monitored anesthesia care<br>Sedation directed by an anesthesiologist in which the used intravenous drugs and target level sedation are chosen by the anesthesiologist. | Procedure: Sedation directed by an anesthesiologist<br>* The choice of the drugs and the target level sedation are directed by an anesthesiologist<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADR with Non-Anesthesiologist administered propofol (NAAP)