Health Trials

Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection.

ConditionsAnesthesia InductionPropofol Pain Injection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMongi Slim Hospital

About this trial

This is a prospective, single-center, randomized, double-blind controlled trial involving patients scheduled for elective surgery requiring general anesthesia with propofol induction. Participants are randomly assigned to one of three groups: the ondansetron group (8 mg IV), the lidocaine group (40 mg IV), or the control group (0.9% normal saline placebo). Study medications are administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.

the goal: To assess the efficacy of intravenous ondansetron versus lidocaine and placebo in reducing the incidence and intensity of pain associated with propofol injection in patients undergoing general anesthesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group C (Control)

    Drug

    Group C (Control): Patients receive 4 mL of 0.9% isotonic normal saline (placebo) administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.

  • Ondansetron 8 mg

    Drug

    Patients received 8 mg of ondansetron diluted to a total volume of 4 mL, administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.

  • Lidocaine %2 ampoule

    Drug

    Patients received 40 mg of lidocaine diluted with 0.9% normal saline to a total volume of 4 mL, administered intravenously over 5 minutes, ending 1 minute before anesthetic induction.

Treatment groups

156 Participants
are divided into 3 treatment groups
Group A: Group C (Control):Placebo comparator 1 intervention
Group B: Group O (Ondansetron)Experimental treatment 1 intervention
Group C: Group L (Lidocaine)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of pain during propofol injection

Time frame
During induction of general anesthesia

Secondary outcomes

1

Intensity of pain during propofol injection

Intensity of pain during propofol injection, assessed using a Numerical Rating Scale (NRS) from 0 to 10: 0: No pain 1-3: Mild pain, or pain reported only in response to questioning 4-6: Moderate pain, or pain reported spontaneously without facial grimacing 7-10: Severe pain, characterized by marked vocal expression, facial grimacing, arm withdrawal, or tears

Time frame
during the induction
2

Incidence of postoperative nausea and vomiting (PONV)

Time frame
During the first 24 hours
3

Patient satisfaction

Patient satisfaction, assessed using a Likert scale;

Time frame
Two hours after surgery
4

Pain recall

Pain recall, evaluated by assessing patients' memory of the injection-related pain.

Time frame
two hours after surgery

Other outcomes

Sponsors and contacts

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

Mongi Slim Hospital

Lead sponsor

Source ClinicalTrials.gov

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