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General Anesthesia; Tracheal IntubationPhase 4NCT07597564

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

A Phase 4 study testing Metoprolol (MET), Sufentanil and Normal Saline (0.9% NaCl) in people with General Anesthesia; Tracheal Intubation, run by Fujian Provincial Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
General Anesthesia; Tracheal Intubation
What is being tested?
Metoprolol (MET), Sufentanil and Normal Saline (0.9% NaCl)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
1 siteChina
Study dates
22 Jun 2026to 22 May 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Fujian provincial hospital

    Fuzhou, Fujian, 350000

    Yanhua Guo, +86-18050333902, guoyanhua19@126.com

Other trials in China

About this study

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

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.

Read more

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.

Being tested
Metoprolol (MET), Sufentanil, Normal Saline (0.9% NaCl)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • SufentanilDrug

    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.

Study groups in NCT07597564
Study groupRoleWhat they receive
Metoprolol 0 mg/kg + Sufentanil 0.1 mcg/kgActive comparatorNot described
Receives: Drug: Sufentanil; Drug: Normal Saline (0.9% NaCl)
Metoprolol 0 mg/kg + Sufentanil 0.2 mcg/kgActive comparatorNot described
Receives: Drug: Sufentanil; Drug: Normal Saline (0.9% NaCl)
Metoprolol 0 mg/kg + Sufentanil 0.3 mcg/kgActive comparatorNot described
Receives: Drug: Sufentanil; Drug: Normal Saline (0.9% NaCl)
Metoprolol 0 mg/kg + Sufentanil 0.4 mcg/kgActive comparatorNot described
Receives: Drug: Sufentanil; Drug: Normal Saline (0.9% NaCl)
Metoprolol 0 mg/kg + Sufentanil 0.5 mcg/kgActive comparatorNot described
Receives: Drug: Sufentanil; Drug: Normal Saline (0.9% NaCl)
Metoprolol 0.1 mg/kg + Sufentanil 0.1 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.1 mg/kg + Sufentanil 0.2 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.1 mg/kg + Sufentanil 0.3 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.1 mg/kg + Sufentanil 0.4 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.1 mg/kg + Sufentanil 0.5 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.2 mg/kg + Sufentanil 0.1 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.2 mg/kg + Sufentanil 0.2 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.2 mg/kg + Sufentanil 0.3 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.2 mg/kg + Sufentanil 0.4 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.2 mg/kg + Sufentanil 0.5 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.3 mg/kg + Sufentanil 0.1 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.3 mg/kg + Sufentanil 0.2 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.3 mg/kg + Sufentanil 0.3 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.3 mg/kg + Sufentanil 0.4 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.3 mg/kg + Sufentanil 0.5 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.4 mg/kg + Sufentanil 0.1 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.4 mg/kg + Sufentanil 0.2 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.4 mg/kg + Sufentanil 0.3 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.4 mg/kg + Sufentanil 0.4 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.4 mg/kg + Sufentanil 0.5 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.5 mg/kg + Sufentanil 0.1 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.5 mg/kg + Sufentanil 0.2 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.5 mg/kg + Sufentanil 0.3 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.5 mg/kg + Sufentanil 0.4 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil
Metoprolol 0.5 mg/kg + Sufentanil 0.5 mcg/kgExperimentalNot described
Receives: Drug: Metoprolol (MET); Drug: Sufentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants achieving hemodynamic stability after tracheal intubation

    Measured: within 0-10 min after intubation

Secondary outcomes (4)
  1. incidence of bradycardia

    Measured: within 0-10 min after intubation

  2. incidence of tachycardia

    Measured: within 0-10 min after intubation

  3. incidence of hypotension

    Measured: within 0-10 min after intubation

  4. incidence of hypertension

    Measured: within 0-10 min after intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start22 Jun 2026 (estimated)
  3. Primary completion22 May 2027 (estimated)
  4. Study completion22 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07597564
Sponsor's protocol ID
K2024-03-015/02
Status last verified
May 2026
First submitted
13 May 2026
Last updated
20 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metoprolol (MET), Sufentanil and Normal Saline (0.9% NaCl) in people with General Anesthesia; Tracheal Intubation, run by Fujian Provincial Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanhua Guo (+86-18050333902, guoyanhua19@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants achieving hemodynamic stability after tracheal intubation (time frame: within 0-10 min after intubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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