Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03922074

Acronym

ADR_NAAP

Enrollment

630

Registered

2019-04-19

Start date

2017-01-02

Completion date

2019-12-31

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADR, Colon Adenoma, Colo-rectal Cancer

Keywords

ADR with Non-Anesthesiologist administered propofol (NAAP)

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).

Interventions

PROCEDURESedation 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.

PROCEDURESedation directed by an anesthesiologist

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

50 Years to 69 Years

Healthy volunteers

Inclusion criteria

Healthy patients -

Exclusion criteria

Patients with familial colorectal cancer history \-

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026