Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol (ADR_NAAP)
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|ClinicalTrials.gov Identifier: NCT03922074|
Recruitment Status : Active, not recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Colo-rectal Cancer Colon Adenoma ADR||Procedure: Sedation directed by an endoscopist Procedure: Sedation directed by an anesthesiologist||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||630 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol. An Equivalence Trial|
|Actual Study Start Date :||January 2, 2017|
|Actual Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Non-anesthesiologist administered propofol
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
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.
Active Comparator: Monitored anesthesia care
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
The choice of the drugs and the target level sedation are directed by an anesthesiologist
- Adenoma detection rate [ Time Frame: 30 days ]Percentage of patients aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected and removed