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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFujian Provincial Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Metoprolol (MET)
  • Sufentanil
  • Normal Saline (0.9% NaCl)

Treatment groups

900 Participants
are divided into 30 treatment groups

30

Treatment groups

See each treatment group below.

Sponsors and collaborators