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Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation
Sponsor: Fujian Provincial Hospital
Summary
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.
Official title: Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation: Prospective Randomized Double-blind Study
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
900
Start Date
2026-06-22
Completion Date
2027-05-22
Last Updated
2026-05-20
Healthy Volunteers
No
Conditions
Interventions
Metoprolol (MET)
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.
Sufentanil
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)
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.
Locations (1)
Fujian provincial hospital
Fuzhou, Fujian, China