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

ConditionAny Patient Under General Anesthesia With Propofol Induction
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasme University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years old.

Undergoing non cardiac surgery under general anesthesia.

Receiving propofol for induction.

No midazolam premedication

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Bolus injection

    Other intervention

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

  • Fractionned onjection

    Other intervention

    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).

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Single bolus injectionActive comparator 1 intervention
Group B: Fractionned injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain on injection

To compare the incidence of postoperative patient-recalled injection pain compared to standard single-bolus administration.

Time frame
6 hour

Secondary outcomes

1

Intensity of pain

The intensity of remembered pain (Visual analog scale 0-10)

Time frame
6 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasme University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: