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Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection.

2. juni 2026 opdateret af: Mhamed Sami Mebazaa, Mongi Slim Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

156

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Mhamed Sami Mebazaa, professor
  • Telefonnummer: 00216 22252589
  • E-mail: msmebazaa@gmail.com

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Group C (Control):
Group C (Control): Patients receive 4 mL of 0.9% isotonic normal saline
Medicin: 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.
Eksperimentel: Group O (Ondansetron)
Group O (Ondansetron): Patients receive 8 mg of ondansetron
Medicin: 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.
Aktiv komparator: Group L (Lidocaine)
Group L (Lidocaine): Patients received 40 mg of lidocaine
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of pain during propofol injection
Tidsramme: During induction of general anesthesia
During induction of general anesthesia

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intensity of pain during propofol injection
Tidsramme: during the induction

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)
Tidsramme: During the first 24 hours
During the first 24 hours
Patient satisfaction
Tidsramme: Two hours after surgery
Patient satisfaction, assessed using a Likert scale;
Two hours after surgery
Pain recall
Tidsramme: two hours after surgery
Pain recall, evaluated by assessing patients' memory of the injection-related pain.
two hours after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mongi Slim Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

8. juni 2026

Primær færdiggørelse (Anslået)

30. juli 2026

Studieafslutning (Anslået)

15. august 2026

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Propofol pain injection

Plan for individuelle deltagerdata (IPD)

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