Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol

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).

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Key information

Conditions

Colo-rectal Cancer ADR Colon Adenoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy patients -

Exclusion criteria

Patients with familial colorectal cancer history

Treatment and study plan

Sedation directed by an endoscopist

Procedure

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.

Sedation directed by an anesthesiologist

Procedure

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Serveis de Salut Integrats Baix Empordà

Other

Registry information

Official study title

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

Acronym: ADR_NAAP

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Apr 19, 2019
Registry last updated: Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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