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Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation

18. května 2026 aktualizováno: Yanhua Guo, Fujian Provincial Hospital

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.

Přehled studie

Typ studie

Intervenční

Zápis (Odhadovaný)

900

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

    • Fujian
      • Fuzhou, Fujian, Čína, 350000
        • Fujian Provincial Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Aktivní komparátor: 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.
Aktivní komparátor: 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.
Aktivní komparátor: 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.
Aktivní komparátor: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Percentage of participants achieving hemodynamic stability after tracheal intubation
Časové okno: within 0-10 min after intubation
within 0-10 min after intubation

Sekundární výstupní opatření

Měření výsledku
Časové okno
incidence of bradycardia
Časové okno: within 0-10 min after intubation
within 0-10 min after intubation
incidence of tachycardia
Časové okno: within 0-10 min after intubation
within 0-10 min after intubation
incidence of hypotension
Časové okno: within 0-10 min after intubation
within 0-10 min after intubation
incidence of hypertension
Časové okno: within 0-10 min after intubation
within 0-10 min after intubation

Další výstupní opatření

Měření výsledku
Časové okno
adverse event
Časové okno: up to 24 hours postoperatively
up to 24 hours postoperatively

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Yanhua Guo, Fujian Provincial Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

22. června 2026

Primární dokončení (Odhadovaný)

22. května 2027

Dokončení studie (Odhadovaný)

22. května 2027

Termíny zápisu do studia

První předloženo

13. května 2026

První předloženo, které splnilo kritéria kontroly kvality

13. května 2026

První zveřejněno (Aktuální)

19. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Sufentanil

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