Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol

NCT03922074 | Completed

• 1 other identifier: 42319_TDA_ANE
• Study Type: interventional
• Target: 630
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Colo-rectal Cancer; Colon Adenoma; ADR

Keywords

ADR with Non-Anesthesiologist administered propofol (NAAP)

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

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

  30 days

Study Arms (2)

Non-anesthesiologist administered propofol

EXPERIMENTAL

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

Monitored anesthesia care

ACTIVE COMPARATOR

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

Interventions

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.

Non-anesthesiologist administered propofol

Sedation directed by an anesthesiologist PROCEDURE

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

Monitored anesthesia care

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy patients -

You may not qualify if:

• Patients with familial colorectal cancer history

Sponsors & Collaborators

• Serveis de Salut Integrats Baix Empordà: lead

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology Department

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 19, 2019
• Study Start: January 2, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09