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NCT07763548
A Novel Two-Step Dosing Induction Strategy (The Propofol Challenge Test) to Minimize Propofol Injection Pain
Conditions: Any Patient Under General Anesthesia With Propofol Induction
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 2000
Sponsor: Erasme University Hospital
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.
Eligibility Criteria
Inclusion Criteria:
* Adults ≥18 years old.
* Undergoing non cardiac surgery under general anesthesia.
* Receiving propofol for induction.
* No midazolam premedication
* 20g IV Catheter below the antecubital fossa used for induction of anesthesia
Exclusion Criteria:
* Emergency surgery.
* Inability to communicate (language or cognitive impairment).
* Pre-induction IV analgesia administration or patients under preoperatively
* Patient with dementia, Alzheimer or other uncontrolled psychiatric diseases that would impact their ability to willingly participate
Source: ClinicalTrials.gov (NCT07763548). StuddyBuddy aggregates publicly available trial information.