- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: Yanhua Guo
- Telefonní číslo: +86-18050333902
- E-mail: guoyanhua19@126.com
Studijní místa
-
-
Fujian
-
Fuzhou, Fujian, Čína, 350000
- Fujian Provincial Hospital
-
Kontakt:
- Yanhua Guo
- Telefonní číslo: +86-18050333902
- E-mail: guoyanhua19@126.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
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
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
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Yanhua Guo, Fujian Provincial Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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