NCT03922074

Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 630 (actual)
• Sponsor: Serveis de Salut Integrats Baix Empordà · Academic / Other
• Sex: All
• Age: 50 Years – 69 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
PROCEDURE	Sedation directed by an anesthesiologist	The choice of the drugs and the target level sedation are directed by an anesthesiologist

Timeline

• Start date: 2017-01-02
• Primary completion: 2018-12-31
• Completion: 2019-12-31
• First posted: 2019-04-19
• Last updated: 2020-09-16