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Status unknownNCT05694585Updated Jan 23, 2023

Effect of Esmolol on Perioperative Stress Reaction

A Phase 4 interventional study of Esmolol and saline in Esmolol, Stress Reaction and Airway Obstruction, sponsored by Xiumei Song. Status unknown. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-01-23.

Sponsored by Xiumei Song · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Esmolol
  • Stress Reaction
  • Airway Obstruction
  • Catecholamine; Overproduction

Keywords

  • continuous infusion
03

In context

Fractures, Stress

173 studies on the registry are indexed under Fractures, Stress; 41 are open to participants now.

This study's planned enrollment of 46 is below the median of 66 across 137 interventional studies indexed under Fractures, Stress.

Browse Fractures, Stress studies →

Lead sponsor

Xiumei Song is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria

  1. The patient and his or her family refused to participate in the study;
  2. Severe respiratory or/cardiovascular or/ neurological disease, or/ hepatic or/renal dysfunction
  3. Those who are allergic to the drugs used in this study;
  4. Psychiatric history or with unstable mental state;
  5. Patients with atrioventricular block
  6. Patients with history of asthma
  7. Patients now treated with β-adrenergic receptor blockers
  8. Patients participating in other clinical trial
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    esmolol group

    esmolol 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.

    Drug: Esmolol

  • Placebo comparator
    Saline solution

    Saline 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.

    Drug: saline

Interventions

  • DrugEsmolol

    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.

    Also known as: Esmolol hydrochloride

  • Drugsaline

    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.

    Also known as: 0.9% sodium chloride injection solution

06

What researchers measure

Primary outcomes

  1. Changes in plasma norepinephrine levels

    level of Norepinephrine

    Time frame: up to 30 minutes after beginning of operation

  2. Changes in plasma epinephrine levels

    level of epinephrine

    Time frame: up to 30 minutes after beginning of operation

  3. Changes in plasma cortisol levels

    level of cortisol

    Time frame: up to 30 minutes after beginning of operation

Secondary outcomes

  1. Hemodynamic changes ：Systolic blood pressure（SBP ）

    Systolic blood pressure (SBP ) during perioperative period

    Time frame: 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

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

  3. Hemodynamic changes ：Heart rate（HR）

    Heart rate（HR） during perioperative period

    Time frame: 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

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

  5. Incidence of adverse reactions: bronchospasm

    Perioperative bronchospasm

    Time frame: 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

    Time frame: Duration from the end of anesthetics infusion to LMA removal

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — demographic data，statistical data，study protocol

Supporting information: Study protocol, Statistical analysis plan

Time frame: after 2024/1/1

Access criteria: undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2023; primary completion for Dec 2023, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2023
First posted
Jan 23, 2023
StartEst.
Feb 1, 2023
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2023
Last update
Jan 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05694585
Lead sponsor
Xiumei Song
Responsible party
Xiumei Song (Associate chief physician, Qianfoshan Hospital) — Sponsor-investigator
First posted
Jan 23, 2023
Start date
Feb 1, 2023 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jan 23, 2023

Study contacts

Xiumei Song, M.D.
Contact
ssm801117@163.com
13969050425
Jinwan Guo, Master
principal investigator · Qianfoshan Hospital
Ling Dong, M.D.
principal investigator · Qianfoshan Hospital
Yang Liu, M.D.
principal investigator · Qianfoshan Hospital
Liang Guo, M.D.
principal investigator · Qianfoshan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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