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

Primary Purpose

Colo-rectal Cancer, Colon Adenoma, ADR

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Sedation directed by an endoscopist

Sedation directed by an anesthesiologist

About this trial

This is an interventional screening trial for Colo-rectal Cancer focused on measuring ADR with Non-Anesthesiologist administered propofol (NAAP)

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Healthy patients -

Exclusion Criteria:

Patients with familial colorectal cancer history

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-anesthesiologist administered propofol

Monitored anesthesia care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Adenoma detection rate

Percentage of patients aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected and removed

Secondary Outcome Measures

Full Information

NCT ID

NCT03922074

First Posted

April 10, 2019

Last Updated

September 13, 2020

Sponsor

Serveis de Salut Integrats Baix Empordà

1. Study Identification

Unique Protocol Identification Number

NCT03922074

Brief Title

Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol

Acronym

ADR_NAAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

January 2, 2017 (Actual)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Serveis de Salut Integrats Baix Empordà

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colo-rectal Cancer, Colon Adenoma, ADR

Keywords

ADR with Non-Anesthesiologist administered propofol (NAAP)

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

630 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-anesthesiologist administered propofol

Arm Type

Experimental

Arm Description

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

Arm Title

Monitored anesthesia care

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Sedation directed by an endoscopist

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Sedation directed by an anesthesiologist

Intervention Description

The choice of the drugs and the target level sedation are directed by an anesthesiologist

Primary Outcome Measure Information:

Title

Adenoma detection rate

Description

Percentage of patients aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected and removed

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol

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