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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C (Control): | Placebo Comparator | Group C (Control): Patients receive 4 mL of 0.9% isotonic normal saline |
|
| Group O (Ondansetron) | Experimental | Group O (Ondansetron): Patients receive 8 mg of ondansetron |
|
| Group L (Lidocaine) | Active Comparator | Group L (Lidocaine): Patients received 40 mg of lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pain during propofol injection | During induction of general anesthesia |
| 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 |
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Inclusion 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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mhamed Sami Mebazaa, professor | Contact | 22252589 | 00216 | msmebazaa@gmail.com |
| Amani Ben Haj youssef, assistant | Contact | 96874336 | 00216 | amani.benhajyoussef@fmt.utm.tn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mongi Slim Hospital | Tunis | 2046 | Tunisia |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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.
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| 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. |
|
| 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 |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |