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

NCT07597564 | Not Yet Recruiting Phase 4

• 1 other identifier: K2024-03-015/02
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthesia; Tracheal Intubation

Outcome Measures

Primary Outcomes (1)

• Percentage of participants achieving hemodynamic stability after tracheal intubation

  within 0-10 min after intubation

Secondary Outcomes (4)

• incidence of bradycardia

  within 0-10 min after intubation

• incidence of tachycardia

  within 0-10 min after intubation

• incidence of hypotension

  within 0-10 min after intubation

• incidence of hypertension

  within 0-10 min after intubation

Other Outcomes (1)

• adverse event

  up to 24 hours postoperatively

Study Arms (30)

Metoprolol 0 mg/kg + Sufentanil 0.1 mcg/kg

ACTIVE COMPARATOR

Drug: Sufentanil; Drug: Normal Saline (0.9% NaCl)

Metoprolol 0 mg/kg + Sufentanil 0.2 mcg/kg

ACTIVE COMPARATOR

Drug: Sufentanil; Drug: Normal Saline (0.9% NaCl)

Metoprolol 0 mg/kg + Sufentanil 0.3 mcg/kg

ACTIVE COMPARATOR

Drug: Sufentanil; Drug: Normal Saline (0.9% NaCl)

Metoprolol 0 mg/kg + Sufentanil 0.4 mcg/kg

ACTIVE COMPARATOR

Drug: Sufentanil; Drug: Normal Saline (0.9% NaCl)

Metoprolol 0 mg/kg + Sufentanil 0.5 mcg/kg

ACTIVE COMPARATOR

Drug: Sufentanil; Drug: Normal Saline (0.9% NaCl)

Metoprolol 0.1 mg/kg + Sufentanil 0.1 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.1 mg/kg + Sufentanil 0.2 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.1 mg/kg + Sufentanil 0.3 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.1 mg/kg + Sufentanil 0.4 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.1 mg/kg + Sufentanil 0.5 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.2 mg/kg + Sufentanil 0.1 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.2 mg/kg + Sufentanil 0.2 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.2 mg/kg + Sufentanil 0.3 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.2 mg/kg + Sufentanil 0.4 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.2 mg/kg + Sufentanil 0.5 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.3 mg/kg + Sufentanil 0.1 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.3 mg/kg + Sufentanil 0.2 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.3 mg/kg + Sufentanil 0.3 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.3 mg/kg + Sufentanil 0.4 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.3 mg/kg + Sufentanil 0.5 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.4 mg/kg + Sufentanil 0.1 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.4 mg/kg + Sufentanil 0.2 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.4 mg/kg + Sufentanil 0.3 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.4 mg/kg + Sufentanil 0.4 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.4 mg/kg + Sufentanil 0.5 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.5 mg/kg + Sufentanil 0.1 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.5 mg/kg + Sufentanil 0.2 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.5 mg/kg + Sufentanil 0.3 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.5 mg/kg + Sufentanil 0.4 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Metoprolol 0.5 mg/kg + Sufentanil 0.5 mcg/kg

EXPERIMENTAL

Drug: Metoprolol (MET); Drug: Sufentanil

Interventions

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.

Metoprolol 0.1 mg/kg + Sufentanil 0.1 mcg/kg; Metoprolol 0.1 mg/kg + Sufentanil 0.2 mcg/kg; Metoprolol 0.1 mg/kg + Sufentanil 0.3 mcg/kg; Metoprolol 0.1 mg/kg + Sufentanil 0.4 mcg/kg; Metoprolol 0.1 mg/kg + Sufentanil 0.5 mcg/kg; Metoprolol 0.2 mg/kg + Sufentanil 0.1 mcg/kg; Metoprolol 0.2 mg/kg + Sufentanil 0.2 mcg/kg; Metoprolol 0.2 mg/kg + Sufentanil 0.3 mcg/kg; Metoprolol 0.2 mg/kg + Sufentanil 0.4 mcg/kg; Metoprolol 0.2 mg/kg + Sufentanil 0.5 mcg/kg; Metoprolol 0.3 mg/kg + Sufentanil 0.1 mcg/kg; Metoprolol 0.3 mg/kg + Sufentanil 0.2 mcg/kg; Metoprolol 0.3 mg/kg + Sufentanil 0.3 mcg/kg; Metoprolol 0.3 mg/kg + Sufentanil 0.4 mcg/kg; Metoprolol 0.3 mg/kg + Sufentanil 0.5 mcg/kg; Metoprolol 0.4 mg/kg + Sufentanil 0.1 mcg/kg; Metoprolol 0.4 mg/kg + Sufentanil 0.2 mcg/kg; Metoprolol 0.4 mg/kg + Sufentanil 0.3 mcg/kg; Metoprolol 0.4 mg/kg + Sufentanil 0.4 mcg/kg; Metoprolol 0.4 mg/kg + Sufentanil 0.5 mcg/kg; Metoprolol 0.5 mg/kg + Sufentanil 0.1 mcg/kg; Metoprolol 0.5 mg/kg + Sufentanil 0.2 mcg/kg; Metoprolol 0.5 mg/kg + Sufentanil 0.3 mcg/kg; Metoprolol 0.5 mg/kg + Sufentanil 0.4 mcg/kg; Metoprolol 0.5 mg/kg + Sufentanil 0.5 mcg/kg

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.

Metoprolol 0 mg/kg + Sufentanil 0.1 mcg/kg; Metoprolol 0 mg/kg + Sufentanil 0.2 mcg/kg; Metoprolol 0 mg/kg + Sufentanil 0.3 mcg/kg; Metoprolol 0 mg/kg + Sufentanil 0.4 mcg/kg; Metoprolol 0 mg/kg + Sufentanil 0.5 mcg/kg; Metoprolol 0.1 mg/kg + Sufentanil 0.1 mcg/kg; Metoprolol 0.1 mg/kg + Sufentanil 0.2 mcg/kg; Metoprolol 0.1 mg/kg + Sufentanil 0.3 mcg/kg; Metoprolol 0.1 mg/kg + Sufentanil 0.4 mcg/kg; Metoprolol 0.1 mg/kg + Sufentanil 0.5 mcg/kg; Metoprolol 0.2 mg/kg + Sufentanil 0.1 mcg/kg; Metoprolol 0.2 mg/kg + Sufentanil 0.2 mcg/kg; Metoprolol 0.2 mg/kg + Sufentanil 0.3 mcg/kg; Metoprolol 0.2 mg/kg + Sufentanil 0.4 mcg/kg; Metoprolol 0.2 mg/kg + Sufentanil 0.5 mcg/kg; Metoprolol 0.3 mg/kg + Sufentanil 0.1 mcg/kg; Metoprolol 0.3 mg/kg + Sufentanil 0.2 mcg/kg; Metoprolol 0.3 mg/kg + Sufentanil 0.3 mcg/kg; Metoprolol 0.3 mg/kg + Sufentanil 0.4 mcg/kg; Metoprolol 0.3 mg/kg + Sufentanil 0.5 mcg/kg; Metoprolol 0.4 mg/kg + Sufentanil 0.1 mcg/kg; Metoprolol 0.4 mg/kg + Sufentanil 0.2 mcg/kg; Metoprolol 0.4 mg/kg + Sufentanil 0.3 mcg/kg; Metoprolol 0.4 mg/kg + Sufentanil 0.4 mcg/kg; Metoprolol 0.4 mg/kg + Sufentanil 0.5 mcg/kg; Metoprolol 0.5 mg/kg + Sufentanil 0.1 mcg/kg; Metoprolol 0.5 mg/kg + Sufentanil 0.2 mcg/kg; Metoprolol 0.5 mg/kg + Sufentanil 0.3 mcg/kg; Metoprolol 0.5 mg/kg + Sufentanil 0.4 mcg/kg; Metoprolol 0.5 mg/kg + Sufentanil 0.5 mcg/kg

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.

Metoprolol 0 mg/kg + Sufentanil 0.1 mcg/kg; Metoprolol 0 mg/kg + Sufentanil 0.2 mcg/kg; Metoprolol 0 mg/kg + Sufentanil 0.3 mcg/kg; Metoprolol 0 mg/kg + Sufentanil 0.4 mcg/kg; Metoprolol 0 mg/kg + Sufentanil 0.5 mcg/kg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Fujian provincial hospital

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Interventions

Metoprolol; Sufentanil; Saline Solution

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yanhua Guo

  Fujian Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanhua Guo

CONTACT

+86-18050333902; guoyanhua19@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): May 22, 2027
• Study Completion (Estimated): May 22, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)