ADR_NAAP: Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol

Sponsor

Serveis de Salut Integrats Baix Empordà (Other)

Overall Status

Completed

CT.gov ID

NCT03922074

Collaborator

(none)

630

Enrollment

Arms

35.9

Actual Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Colo-rectal Cancer Colon Adenoma ADR	Procedure: Sedation directed by an endoscopist Procedure: Sedation directed by an anesthesiologist	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

630 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jan 2, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Adenoma detection rate [30 days]
Percentage of patients aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected and removed

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Healthy patients -

Exclusion Criteria:

Patients with familial colorectal cancer history

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Serveis de Salut Integrats Baix Empordà

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marco Alburquerque, Head of Gastroenterology Department, Serveis de Salut Integrats Baix Empordà

ClinicalTrials.gov Identifier:

NCT03922074

Other Study ID Numbers:

42319_TDA_ANE

First Posted:

Apr 19, 2019

Last Update Posted:

Sep 16, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marco Alburquerque, Head of Gastroenterology Department, Serveis de Salut Integrats Baix Empordà

ADR with Non-Anesthesiologist administered propofol (NAAP)

Additional relevant MeSH terms:

Adenoma

Study Results

No Results Posted as of Sep 16, 2020