Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia Induction; Propofol Pain Injection
• Intervention / Treatment: Drug: Group C (Control); Drug: Ondansetron 8 mg; Drug: Lidocaine %2 ampoule

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mhamed Sami Mebazaa, professor; Phone Number: 00216 22252589; Email: msmebazaa@gmail.com
• Study Contact Backup: Name: Amani Ben Haj youssef, assistant; Phone Number: 00216 96874336; Email: amani.benhajyoussef@fmt.utm.tn

Study Locations

• Tunisia
  • Tunis, Tunisia, 2046
    • Mongi Slim Hospital
    • Contact: Amani Ben Haj youssef; Phone Number: 96874336; Email: amani.benhajyoussef@fmt.utm.tn
    • Contact: Email: amani.benhajyoussef@fmt.utm.tn
    • Principal Investigator: Amani Ben Haj youssef, Assistant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group C (Control): Group C (Control): Patients receive 4 mL of 0.9% isotonic normal saline	Drug: Group C (Control); 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.
Experimental: Group O (Ondansetron); Group O (Ondansetron): Patients receive 8 mg of ondansetron	Drug: Ondansetron 8 mg; 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.
Active Comparator: Group L (Lidocaine); Group L (Lidocaine): Patients received 40 mg of lidocaine	Drug: Lidocaine %2 ampoule; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of pain during propofol injection	During induction of general anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	during the induction
Incidence of postoperative nausea and vomiting (PONV)		During the first 24 hours
Patient satisfaction	Patient satisfaction, assessed using a Likert scale;	Two hours after surgery
Pain recall	Pain recall, evaluated by assessing patients' memory of the injection-related pain.	two hours after surgery

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 8, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Imidazoles; Indoles; Heterocyclic Compounds, 3-Ring; Carbazoles; Ondansetron
• Other Study ID Numbers: Propofol pain injection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No