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NOT YET RECRUITING
NCT07763548
PHASE4

A Novel Two-Step Dosing Induction Strategy (The Propofol Challenge Test) to Minimize Propofol Injection Pain

Sponsor: Erasme University Hospital

View on ClinicalTrials.gov

Summary

Propofol is the most widely used intravenous hypnotic agent for the induction of general anesthesia owing to its rapid onset and short duration of action. Despite its favorable pharmacokinetics and widespread use, a notable drawback persists: the incidence of pain on injection. Statistics on the matter are widely variable, but some estimates indicate that the incidence of pain with propofol injection is around 70%1. To date, no studies have systematically evaluated whether dividing the induction dose of propofol-starting with a small sub-induction bolus (e.g., 20 mg) followed by the remainder-can reduce pain perception. We hypothesize that a two-step administration of propofol-consisting of a small initial dose followed by the remaining dose-may serve as a nociceptive preconditioning stimulus and reduce postoperative patient-recalled injection pain compared to standard single-bolus administration.

Official title: A Novel Two-Step Dosing Induction Strategy (The Propofol Challenge Test) to Minimize Propofol Injection Pain: A Time-block-Allocated Comparative Effectiveness Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2026-10-02

Completion Date

2028-06-30

Last Updated

2026-08-13

Healthy Volunteers

No

Interventions

OTHER

Bolus injection

During Months 1, 3, 5 and 7 patients will receive a full single bolus of propofol

OTHER

Fractionned onjection

During Months 2, 4, 6 and 8 patients will receive the same total dose but delivered in two sequential injections: an initial subdose (e.g., 20 mg), followed by the remainder of the dose after a brief interval (e.g., 30 seconds).