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NCT Number: NCT07597564

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

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.

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Key information

Conditions

General Anesthesia; Tracheal Intubation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Percentage of participants achieving hemodynamic stability after tracheal intubation

    Time frame: within 0-10 min after intubation

Secondary outcomes

  1. incidence of bradycardia

    Time frame: within 0-10 min after intubation

  2. incidence of tachycardia

    Time frame: within 0-10 min after intubation

  3. incidence of hypotension

    Time frame: within 0-10 min after intubation

  4. incidence of hypertension

    Time frame: within 0-10 min after intubation

Other outcomes

  1. adverse event

    Time frame: up to 24 hours postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Yanhua Guo

CONTACT

[email protected]

+86-18050333902

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Official study title

Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation: Prospective Randomized Double-blind Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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