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NCT Number: NCT07632144

Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This prospective, single-center, randomized, double-blind controlled trial is conducted at the operating theaters of the Mongi Slim University Hospital (Tunisia). The study aime to compare the effectiveness of intravenous ondansetron and lidocaine versus placebo in preventing pain associated with propofol injection during induction of general anesthesia.

Adult patients (ASA I-III) scheduled for elective surgery requiring propofol-based induction are randomly allocated in a 1:1:1 ratio to receive either ondansetron 8 mg, lidocaine 40 mg, or normal saline placebo before anesthesia induction. The primary outcome is the incidence of pain during propofol injection, while secondary outcomes include pain intensity, postoperative nausea and vomiting, patient satisfaction, and pain recall.

A total of 156 patients are planned for inclusion. Pain is assessed immediately after administration of an initial propofol bolus using a numerical rating scale (0-10) by a blinded observer. The study is designed to determine whether ondansetron could provide analgesic efficacy comparable to the current standard treatment, lidocaine, while also offering potential benefits related to the prevention of postoperative nausea and vomiting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The study included patients who met all of the following criteria:

Aged 18 years or older; Classified as ASA physical status I-III (Appendix 1); Provided written informed consent to participate in the study; Scheduled for elective surgery requiring general anesthesia with propofol induction.

Exclusion criteria

  • Patients were not eligible for inclusion if they:

Had received analgesics or antiemetics within 12 hours before surgery; Had communication difficulties or were unable to assess pain adequately (e.g., language barrier, dementia, impaired consciousness); Had a known allergy to ondansetron, lidocaine, or propofol; Did not receive propofol for anesthetic induction; Were pregnant or breastfeeding; Suffered from chronic pain or regularly used opioid medications; Did not have a 20-gauge intravenous catheter inserted on the dorsum of the hand; Declined participation in the study.

Patients were excluded from the study if they experienced any complication during anesthetic induction, including:

Anaphylactic shock or allergic reaction to study medications; Hemodynamic or respiratory instability.

Patients who subsequently withdrew their consent were also excluded from the study.

Treatment and study plan

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.

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

    Time frame: during the induction

    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

  2. Incidence of postoperative nausea and vomiting (PONV)

    Time frame: During the first 24 hours

  3. Patient satisfaction

    Time frame: Two hours after surgery

    Patient satisfaction, assessed using a Likert scale;

  4. Pain recall

    Time frame: two hours after surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amani Ben Haj youssef, assistant

CONTACT

[email protected]

96874336 ext. 00216

Mhamed Sami Mebazaa, professor

CONTACT

[email protected]

22252589 ext. 00216

Sponsors and collaborators

Lead sponsor

Mongi Slim Hospital

Other

Registry information

Official study title

Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection: a Randomized Controlled Trial.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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