Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol

NCT ID: NCT03922074

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 630 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-02
• Study Completion Date: 2019-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Non-anesthesiologist administered propofol

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

Group Type: EXPERIMENTAL

Sedation directed by an endoscopist

Intervention Type: 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.

Monitored anesthesia care

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

Group Type: ACTIVE_COMPARATOR

Sedation directed by an anesthesiologist

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Sedation directed by an anesthesiologist

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Healthy patients -

Exclusion Criteria

Patients with familial colorectal cancer history

-

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Serveis de Salut Integrats Baix Empordà

OTHER

Sponsor Role: lead

Responsible Party

Marco Alburquerque

Head of Gastroenterology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

42319_TDA_ANE

Identifier Type: -

Identifier Source: org_study_id