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

September 13, 2020 updated by: Marco Alburquerque, Serveis de Salut Integrats Baix Empordà

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

630

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy patients -

Exclusion Criteria:

Patients with familial colorectal cancer history

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Serveis de Salut Integrats Baix Empordà

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2017

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (ACTUAL)

April 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 13, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42319_TDA_ANE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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