- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07597564
Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation
Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation: Prospective Randomized Double-blind Study
This randomized, double-blind, controlled clinical study will evaluate the effects of different dose combinations of intravenous metoprolol and sufentanil on cardiovascular responses during oral endotracheal intubation under general anesthesia.
Endotracheal intubation may cause transient increases in heart rate and blood pressure due to sympathetic stimulation. This study aims to determine whether metoprolol, in combination with different doses of sufentanil, can improve hemodynamic stability during and after intubation.
A total of 900 adult patients aged 18 to 65 years with American Society of Anesthesiologists physical status I or II who are scheduled for elective non-cardiac surgery under general anesthesia with endotracheal intubation will be enrolled. Participants will be randomly assigned to one of 30 groups according to the combination of metoprolol dose and sufentanil dose. Metoprolol doses include 0, 0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg, and sufentanil doses include 0.1, 0.2, 0.3, 0.4, and 0.5 mcg/kg.
All participants will receive standardized anesthetic induction and maintenance. Hemodynamic changes will be observed for 10 minutes after intubation. The main outcome is the success rate of hemodynamic stability within 0 to 10 minutes after intubation. Secondary outcomes include the incidence of hypotension, hypertension, bradycardia, and tachycardia.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Yanhua Guo
- Numero di telefono: +86-18050333902
- Email: guoyanhua19@126.com
Luoghi di studio
-
-
Fujian
-
Fuzhou, Fujian, Cina, 350000
- Fujian Provincial Hospital
-
Contatto:
- Yanhua Guo
- Numero di telefono: +86-18050333902
- Email: guoyanhua19@126.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Age 18 to 65 years.
- American Society of Anesthesiologists physical status I or II.
- Scheduled for elective non-cardiac surgery.
- Planned general anaesthesia with endotracheal intubation.
Exclusion Criteria:
- Cardiovascular or respiratory diseases, such as uncontrolled hypertension or bronchial asthma.
- Current use of β-blockers.
- History of chronic drug use or alcohol abuse.
- Hepatic or renal impairment.
- Known allergy to any study drug.
- Anticipated difficult airway.
- Any other condition that may affect the conduct of the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Metoprolol 0 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Comparatore attivo: Metoprolol 0 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Comparatore attivo: Metoprolol 0 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Comparatore attivo: Metoprolol 0 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Comparatore attivo: Metoprolol 0 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Sperimentale: Metoprolol 0.1 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.1 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.1 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.1 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.1 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.2 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.2 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.2 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.2 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.2 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.3 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.3 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.3 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.3 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.3 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.4 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.4 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.4 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.4 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.4 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.5 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.5 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.5 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.5 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Sperimentale: Metoprolol 0.5 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Percentage of participants achieving hemodynamic stability after tracheal intubation
Lasso di tempo: within 0-10 min after intubation
|
within 0-10 min after intubation
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
incidence of bradycardia
Lasso di tempo: within 0-10 min after intubation
|
within 0-10 min after intubation
|
|
incidence of tachycardia
Lasso di tempo: within 0-10 min after intubation
|
within 0-10 min after intubation
|
|
incidence of hypotension
Lasso di tempo: within 0-10 min after intubation
|
within 0-10 min after intubation
|
|
incidence of hypertension
Lasso di tempo: within 0-10 min after intubation
|
within 0-10 min after intubation
|
Altre misure di risultato
Misura del risultato |
Lasso di tempo |
|---|---|
|
adverse event
Lasso di tempo: up to 24 hours postoperatively
|
up to 24 hours postoperatively
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Yanhua Guo, Fujian Provincial Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- K2024-03-015/02
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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