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EsmololPhase 4NCT05694585

Effect of Esmolol on Perioperative Stress Reaction

A Phase 4 study testing Esmolol and saline in people with Esmolol and Stress Reaction, run by Xiumei Song.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to observe the effect of low dose continuous infusion of esmolol on perioperative stress response in patients undergoing airway intervention . Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Esmolol, Stress Reaction, Airway Obstruction
What is being tested?
Esmolol and saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
No sites listed yet
Study dates
1 Feb 2023to 31 Dec 2023
Phase
Phase 4
Are there results?
None posted in the registry

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) Physical Status I to III.;
  • Body mass index (BMI): 20-30 kg/m2;
  • Elective airway intervention under general anesthesia with jet ventilation，duration of operation less than 2hs;
  • Sign informed consent for clinical trial

Who cannot join

  • The patient and his or her family refused to participate in the study;
  • Severe respiratory or/cardiovascular or/ neurological disease, or/ hepatic or/renal dysfunction
  • Those who are allergic to the drugs used in this study;
  • Psychiatric history or with unstable mental state;
  • Patients with atrioventricular block
  • Patients with history of asthma
  • Patients now treated with β-adrenergic receptor blockers
  • Patients participating in other clinical trial

Trial locations and contacts

No sites are listed yet.

Xiumei Song, M.D. contact

13969050425

ssm801117@163.com

About this study

Official title: Effect of Continuous Infusion of Esmolol on Perioperative Stress Reaction in Patients Undergoing Airway Intervention

The goal of this clinical trial is to observe the effect of low dose continuous infusion of esmolol on perioperative stress response in patients undergoing airway intervention .

Read the detailed description

Airway intervention is known to activate stress response and release catecholamines resulting in severe hemodynamic instability. Various techniques which are recommended to prevent the stress response include increasing the depth of anesthesia, improving surgical procedures and the use of various pharmacological agents. Esmolol blocks the action of the endogenous catecholamines, we plan low dose esmolol infusion decrease stress response and hemodynamic fluctuation during airway intervention.

46 patients scheduled airway intervention under general anesthesia were randomly divided into esmolol group and control group. esmolol 50μg/kg/min or saline 50μg/kg/min were iv administered before Operation beginning. If HR（heart rate）is greater than 90 beats/min, esmolol or saline 50μg/kg/min is added each time, with interval more than 5 min and the peak value is 200 μg/kg/min. If the heart rate is lower than 60 times/minute, Stop medication. Plasma level of Norepinephrine, epinephrine, and cortisol before induction of anesthesia and 30 minutes after beginning of operation were determined by high-performance liquid chromatography. Perioperative hemodynamics changes, extubation time, incidence of severe sinus bradycardia and bronchospasm were recorded.

Being tested
Esmolol, saline
Keywords
continuous infusion
Medical subject headings
Fractures, Stress, Airway Obstruction

What participants receive

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

  • EsmololDrug

    Also called Esmolol hydrochloride

    Esmolol 50μg/kg /min is intravenously administered before Operation beginning. If HR（heart rate）is greater than 90 beats/min, esmolol 50μg/kg/min is added each time, with interval more than 5 min and the peak value is 200 μg/kg/min. If the heart rate is lower than 60 times/minute, Stop medication.

  • salineDrug

    Also called 0.9% sodium chloride injection solution

    Saline 50μg/kg /min were iv administered before Operation beginning. If HR（heart rate）is greater than 90 beats/min, saline 50μg/kg/min is added each time, with interval more than 5 min and the peak value is 200 μg/kg/min. If the heart rate is lower than 60 times/minute, Stop medication.

Study groups in NCT05694585
Study groupRoleWhat they receive
esmolol groupExperimentalesmolol group: esmolol 50 μg/kg /min were intravenously administered before Operation beginning. If HR（heart rate）is greater than 90 beats/min, esmolol 50μg/kg /min is added each time, with interval more than 5 min and the peak value is 200 μg/kg/min. If the heart rate is lower than 60 times/minute, Stop medication.
Receives: Drug: Esmolol
Saline solutionPlacebo comparatorSaline group: saline 50 μg/kg /min were intravenously administered before Operation beginning. If HR（heart rate）is greater than 90 beats/min, saline 50μg/kg /min is added each time, with interval more than 5 min and the peak value is 200 μg/kg/min. If the heart rate is lower than 60 times/minute, Stop medication.
Receives: Drug: saline

What is being measured

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

  1. Changes in plasma norepinephrine levels

    level of Norepinephrine

    Measured: up to 30 minutes after beginning of operation

  2. Changes in plasma epinephrine levels

    level of epinephrine

    Measured: up to 30 minutes after beginning of operation

  3. Changes in plasma cortisol levels

    level of cortisol

    Measured: up to 30 minutes after beginning of operation

Secondary outcomes (6)

  1. Hemodynamic changes ：Systolic blood pressure（SBP ）

    Systolic blood pressure (SBP ) during perioperative period

    Measured: from anesthesia induction to 30 minutes after remove the laryngeal mask

  2. Hemodynamic changes ：Diastolic blood pressure（ DBP）

    Diastolic blood pressure（ DBP） during perioperative period

    Measured: from anesthesia induction to 30 minutes after remove the laryngeal mask

  3. Hemodynamic changes ：Heart rate（HR）

    Heart rate（HR） during perioperative period

    Measured: from anesthesia induction to 30 minutes after remove the laryngeal mask

  4. Incidence of adverse reactions: Severe sinus bradycardia

    Severe sinus bradycardia: HR<40 times/min during perioperative period

    Measured: from anesthesia induction to 30 minutes after remove the laryngeal mask

  5. Incidence of adverse reactions: bronchospasm

    Perioperative bronchospasm

    Measured: from anesthesia induction to 30 minutes after remove the laryngeal mask

  6. Laryngeal mask airway (LMA) removal time

    Duration from the end of anesthetics infusion to LMA removal

    Measured: Duration from the end of anesthetics infusion to LMA removal

Timeline

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

  1. First posted23 Jan 2023
  2. Study start1 Feb 2023 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05694585
Sponsor's protocol ID
YXLL-KY-2022(107)
Status last verified
Jan 2023
First submitted
5 Jan 2023
Last updated
23 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: demographic data，statistical data，study protocol

Publications

  • Lakhe G, Pradhan S, Dhakal S. Hemodynamic Response to Laryngoscopy and Intubation Using McCoy Laryngoscope: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2021 Jul 1;59(238):554-557. doi: 10.31729/jnma.6752.

    PubMed 34508397

  • Hoshijima H, Maruyama K, Mihara T, Boku AS, Shiga T, Nagasaka H. Use of the GlideScope does not lower the hemodynamic response to tracheal intubation more than the Macintosh laryngoscope: a systematic review and meta-analysis. Medicine (Baltimore). 2020 Nov 25;99(48):e23345. doi: 10.1097/MD.0000000000023345.

    PubMed 33235101

  • Mendonca FT, Silva SLD, Nilton TM, Alves IRR. Effects of lidocaine and esmolol on hemodynamic response to tracheal intubation: a randomized clinical trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):95-102. doi: 10.1016/j.bjane.2021.01.014. Epub 2021 Sep 25.

    PubMed 34582903

  • Efe EM, Bilgin BA, Alanoglu Z, Akbaba M, Denker C. Comparison of bolus and continuous infusion of esmolol on hemodynamic response to laryngoscopy, endotracheal intubation and sternotomy in coronary artery bypass graft. Braz J Anesthesiol. 2014 Jul-Aug;64(4):247-52. doi: 10.1016/j.bjane.2013.07.003. Epub 2013 Oct 25.

    PubMed 24998108

  • Hasegawa D, Sato R, Prasitlumkum N, Nishida K, Takahashi K, Yatabe T, Nishida O. Effect of Ultrashort-Acting beta-Blockers on Mortality in Patients With Sepsis With Persistent Tachycardia Despite Initial Resuscitation: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Chest. 2021 Jun;159(6):2289-2300. doi: 10.1016/j.chest.2021.01.009. Epub 2021 Jan 9.

    PubMed 33434497

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Esmolol and saline in people with Esmolol and Stress Reaction, run by Xiumei Song.

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 8 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: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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

Contact Xiumei Song, M.D. (13969050425, ssm801117@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in plasma norepinephrine levels (time frame: up to 30 minutes after beginning of operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05694585, which also lists 5 linked publications.

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 23 Jan 2023.

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