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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03922074
Other study ID # 42319_TDA_ANE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

-

Study Design


Related Conditions & MeSH terms


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
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