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

ConditionGeneral Anesthesia; 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Metoprolol (MET)
Drug
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
Drug
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)
Drug
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.

Treatment groups

900 Participants

are divided into 30 treatment groups

Treatment groups

See each treatment group below.

Group A: Metoprolol 0 mg/kg + Sufentanil 0.1 mcg/kgActive comparator 2 interventions

Group B: Metoprolol 0 mg/kg + Sufentanil 0.2 mcg/kgActive comparator 2 interventions

Group C: Metoprolol 0 mg/kg + Sufentanil 0.3 mcg/kgActive comparator 2 interventions

Group D: Metoprolol 0 mg/kg + Sufentanil 0.4 mcg/kgActive comparator 2 interventions

Group E: Metoprolol 0 mg/kg + Sufentanil 0.5 mcg/kgActive comparator 2 interventions

Group F: Metoprolol 0.1 mg/kg + Sufentanil 0.1 mcg/kgExperimental treatment 2 interventions

Group G: Metoprolol 0.1 mg/kg + Sufentanil 0.2 mcg/kgExperimental treatment 2 interventions

Group H: Metoprolol 0.1 mg/kg + Sufentanil 0.3 mcg/kgExperimental treatment 2 interventions

Group I: Metoprolol 0.1 mg/kg + Sufentanil 0.4 mcg/kgExperimental treatment 2 interventions

Group J: Metoprolol 0.1 mg/kg + Sufentanil 0.5 mcg/kgExperimental treatment 2 interventions

Group K: Metoprolol 0.2 mg/kg + Sufentanil 0.1 mcg/kgExperimental treatment 2 interventions

Group L: Metoprolol 0.2 mg/kg + Sufentanil 0.2 mcg/kgExperimental treatment 2 interventions

Group M: Metoprolol 0.2 mg/kg + Sufentanil 0.3 mcg/kgExperimental treatment 2 interventions

Group N: Metoprolol 0.2 mg/kg + Sufentanil 0.4 mcg/kgExperimental treatment 2 interventions

Group O: Metoprolol 0.2 mg/kg + Sufentanil 0.5 mcg/kgExperimental treatment 2 interventions

Group P: Metoprolol 0.3 mg/kg + Sufentanil 0.1 mcg/kgExperimental treatment 2 interventions

Group Q: Metoprolol 0.3 mg/kg + Sufentanil 0.2 mcg/kgExperimental treatment 2 interventions

Group R: Metoprolol 0.3 mg/kg + Sufentanil 0.3 mcg/kgExperimental treatment 2 interventions

Group S: Metoprolol 0.3 mg/kg + Sufentanil 0.4 mcg/kgExperimental treatment 2 interventions

Group T: Metoprolol 0.3 mg/kg + Sufentanil 0.5 mcg/kgExperimental treatment 2 interventions

Group U: Metoprolol 0.4 mg/kg + Sufentanil 0.1 mcg/kgExperimental treatment 2 interventions

Group V: Metoprolol 0.4 mg/kg + Sufentanil 0.2 mcg/kgExperimental treatment 2 interventions

Group W: Metoprolol 0.4 mg/kg + Sufentanil 0.3 mcg/kgExperimental treatment 2 interventions

Group X: Metoprolol 0.4 mg/kg + Sufentanil 0.4 mcg/kgExperimental treatment 2 interventions

Group Y: Metoprolol 0.4 mg/kg + Sufentanil 0.5 mcg/kgExperimental treatment 2 interventions

Group Z: Metoprolol 0.5 mg/kg + Sufentanil 0.1 mcg/kgExperimental treatment 2 interventions

Group [: Metoprolol 0.5 mg/kg + Sufentanil 0.2 mcg/kgExperimental treatment 2 interventions

Group \: Metoprolol 0.5 mg/kg + Sufentanil 0.3 mcg/kgExperimental treatment 2 interventions

Group ]: Metoprolol 0.5 mg/kg + Sufentanil 0.4 mcg/kgExperimental treatment 2 interventions

Group ^: Metoprolol 0.5 mg/kg + Sufentanil 0.5 mcg/kgExperimental treatment 2 interventions