Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol

Colo-rectal Cancer Clinical Trial

— ADR_NAAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922074
• Other study ID #: 42319_TDA_ANE
• Status: Completed
• Phase: N/A
• Start date: January 2, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: Serveis de Salut Integrats Baix Empordà
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

Inclusion Criteria:

Healthy patients -

Exclusion Criteria:

Patients with familial colorectal cancer history

-

Related Conditions & MeSH terms

• Adenoma
• ADR
• Colo-rectal Cancer
• Colon Adenoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Serveis de Salut Integrats Baix Empordà

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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