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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
Sponsor:
Information provided by (Responsible Party):
Marco Alburquerque, 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).


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Propofol

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Healthy patients -

Exclusion Criteria:

Patients with familial colorectal cancer history

-


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Responsible Party: Marco Alburquerque, Head of Gastroenterology Department, Serveis de Salut Integrats Baix Empordà
ClinicalTrials.gov Identifier: NCT03922074     History of Changes
Other Study ID Numbers: 42319_TDA_ANE
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Alburquerque, Serveis de Salut Integrats Baix Empordà:
ADR with Non-Anesthesiologist administered propofol (NAAP)
Additional relevant MeSH terms:
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Adenoma
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colonic Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics