Anesthesia InductionNCT07632144
Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection.
A study testing Ondansetron 8 mg and Lidocaine %2 ampoule in people with Anesthesia Induction and Propofol Pain Injection, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
This is a prospective, single-center, randomized, double-blind controlled trial involving patients scheduled for elective surgery requiring general anesthesia with propofol induction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia Induction, Propofol Pain Injection
- What is being tested?
- Ondansetron 8 mg and Lidocaine %2 ampoule
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteTunisia
- Study dates
- 8 Jun 2026to 15 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site
Mongi Slim Hospital
Tunis, 2046
Amani Ben Haj youssef, 96874336, amani.benhajyoussef@fmt.utm.tn
amani.benhajyoussef@fmt.utm.tn
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia Induction, Propofol Pain Injection
- Being tested
- Group C (Control), Ondansetron 8 mg, Lidocaine %2 ampoule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 mgDrug
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 ampouleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group C (Control): | Placebo comparator | Group C (Control): Patients receive 4 mL of 0.9% isotonic normal saline Receives: Drug: Group C (Control) |
| Group O (Ondansetron) | Experimental | Group O (Ondansetron): Patients receive 8 mg of ondansetron Receives: Drug: Ondansetron 8 mg |
| Group L (Lidocaine) | Active comparator | Group L (Lidocaine): Patients received 40 mg of lidocaine Receives: Drug: Lidocaine %2 ampoule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pain during propofol injection
Measured: During induction of general anesthesia
Secondary outcomes (4)
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
Measured: during the induction
Incidence of postoperative nausea and vomiting (PONV)
Measured: During the first 24 hours
Patient satisfaction
Patient satisfaction, assessed using a Likert scale;
Measured: Two hours after surgery
Pain recall
Pain recall, evaluated by assessing patients' memory of the injection-related pain.
Measured: two hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start8 Jun 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632144
- Sponsor's protocol ID
- Propofol pain injection
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No