Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection.

NCT07632144 | Not Yet Recruiting

• 1 other identifier: Propofol pain injection
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia Induction; Propofol Pain Injection

Outcome Measures

Primary Outcomes (1)

• Incidence of pain during propofol injection

  During induction of general anesthesia

Secondary Outcomes (4)

• Intensity of pain during propofol injection

  during the induction

• Incidence of postoperative nausea and vomiting (PONV)

  During the first 24 hours

• Patient satisfaction

  Two hours after surgery

• Pain recall

  two hours after surgery

Study Arms (3)

Group C (Control):

PLACEBO COMPARATOR

Group C (Control): Patients receive 4 mL of 0.9% isotonic normal saline

Drug: Group C (Control)

Group O (Ondansetron)

EXPERIMENTAL

Group O (Ondansetron): Patients receive 8 mg of ondansetron

Drug: Ondansetron 8 mg

Group L (Lidocaine)

ACTIVE COMPARATOR

Group L (Lidocaine): Patients received 40 mg of lidocaine

Drug: Lidocaine %2 ampoule

Interventions

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.

Group C (Control):

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.

Group O (Ondansetron)

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.

Group L (Lidocaine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mongi Slim Hospital: lead

Study Sites (1)

Mongi Slim Hospital

Tunis, 2046, Tunisia

Location

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Mhamed Sami Mebazaa, professor

CONTACT

22252589; msmebazaa@gmail.com

Amani Ben Haj youssef, assistant

CONTACT

96874336; amani.benhajyoussef@fmt.utm.tn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor head of anesthesiology and ICU department

Model Details: Eligible patients are randomly assigned to one of three groups: Group O (Ondansetron): Patients receive 8 mg of ondansetron diluted to a total volume of 4 mL, administered intravenously over 5 minutes, ending 1 minute before anesthetic induction. Group L (Lidocaine): Patients receive 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. 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.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)