drugset / Trial / NCT07166640

Propofol Dose-Finding for Colonoscope Insertion in Adult Patients

NCT07166640

Completed 27 enrolled Kocaeli City Hospital
NaSingle-groupOpen-labelTreatment

Summary

The aim of this prospective dose-finding study is to determine the ED50 of propofol required for successful colonoscope insertion in adult patients. The study is designed using Dixon's up-and-down sequential allocation method. Successful colonoscope insertion is defined as the absence of pain, movement, or vocal response, together with a MOAA/S score ≤2 at the second minute after induction, and maintained until the colonoscope passes the rectosigmoid junction. In cases of failure, an additional dose of propofol is administered, and the initial dose for the next patient is increased by 0.1 mg/kg. In cases of success, the initial dose for the next patient is decreased by 0.1 mg/kg. The primary outcome is the determination of the ED50 of propofol for successful colonoscope insertion until passage of the rectosigmoid junction.

Timeline

Start
2025-09-12
Primary completion
2025-10-15
Completion
2025-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 1.5 mg/kg Intravenous

Indications

No indication recorded.