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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mhamed Sami Mebazaa, professor
- Numéro de téléphone: 00216 22252589
- E-mail: msmebazaa@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Amani Ben Haj youssef, assistant
- Numéro de téléphone: 00216 96874336
- E-mail: amani.benhajyoussef@fmt.utm.tn
Lieux d'étude
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Tunis, Tunisie, 2046
- Mongi Slim Hospital
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Contact:
- Amani Ben Haj youssef
- Numéro de téléphone: 96874336
- E-mail: amani.benhajyoussef@fmt.utm.tn
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Contact:
- E-mail: amani.benhajyoussef@fmt.utm.tn
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Chercheur principal:
- Amani Ben Haj youssef, Assistant
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: Group C (Control):
Group C (Control): Patients receive 4 mL of 0.9% isotonic normal saline
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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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Expérimental: Group O (Ondansetron)
Group O (Ondansetron): Patients receive 8 mg of ondansetron
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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.
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Comparateur actif: Group L (Lidocaine)
Group L (Lidocaine): Patients received 40 mg of lidocaine
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Incidence of pain during propofol injection
Délai: During induction of general anesthesia
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During induction of general anesthesia
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Intensity of pain during propofol injection
Délai: during the induction
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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
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Incidence of postoperative nausea and vomiting (PONV)
Délai: During the first 24 hours
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During the first 24 hours
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Patient satisfaction
Délai: Two hours after surgery
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Patient satisfaction, assessed using a Likert scale;
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Two hours after surgery
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Pain recall
Délai: two hours after surgery
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Pain recall, evaluated by assessing patients' memory of the injection-related pain.
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two hours after surgery
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Propofol pain injection
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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