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Effect of Esmolol on Perioperative Stress Reaction

Primary Purpose

Esmolol, Stress Reaction, Airway Obstruction

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Esmolol
saline
Sponsored by
Xiumei Song
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esmolol focused on measuring continuous infusion

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria 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 Exclusion criteria 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    esmolol group

    Saline solution

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Changes in plasma norepinephrine levels
    level of Norepinephrine
    Changes in plasma epinephrine levels
    level of epinephrine
    Changes in plasma cortisol levels
    level of cortisol

    Secondary Outcome Measures

    Hemodynamic changes :Systolic blood pressure(SBP )
    Systolic blood pressure (SBP ) during perioperative period
    Hemodynamic changes :Diastolic blood pressure( DBP)
    Diastolic blood pressure( DBP) during perioperative period
    Hemodynamic changes :Heart rate(HR)
    Heart rate(HR) during perioperative period
    Incidence of adverse reactions: Severe sinus bradycardia
    Severe sinus bradycardia: HR<40 times/min during perioperative period
    Incidence of adverse reactions: bronchospasm
    Perioperative bronchospasm
    Laryngeal mask airway (LMA) removal time
    Duration from the end of anesthetics infusion to LMA removal

    Full Information

    First Posted
    January 5, 2023
    Last Updated
    January 20, 2023
    Sponsor
    Xiumei Song
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05694585
    Brief Title
    Effect of Esmolol on Perioperative Stress Reaction
    Official Title
    Effect of Continuous Infusion of Esmolol on Perioperative Stress Reaction in Patients Undergoing Airway Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Xiumei Song

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 .
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esmolol, Stress Reaction, Airway Obstruction, Catecholamine; Overproduction
    Keywords
    continuous infusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    esmolol group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Saline solution
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Esmolol
    Other Intervention Name(s)
    Esmolol hydrochloride
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    saline
    Other Intervention Name(s)
    0.9% sodium chloride injection solution
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in plasma norepinephrine levels
    Description
    level of Norepinephrine
    Time Frame
    up to 30 minutes after beginning of operation
    Title
    Changes in plasma epinephrine levels
    Description
    level of epinephrine
    Time Frame
    up to 30 minutes after beginning of operation
    Title
    Changes in plasma cortisol levels
    Description
    level of cortisol
    Time Frame
    up to 30 minutes after beginning of operation
    Secondary Outcome Measure Information:
    Title
    Hemodynamic changes :Systolic blood pressure(SBP )
    Description
    Systolic blood pressure (SBP ) during perioperative period
    Time Frame
    from anesthesia induction to 30 minutes after remove the laryngeal mask
    Title
    Hemodynamic changes :Diastolic blood pressure( DBP)
    Description
    Diastolic blood pressure( DBP) during perioperative period
    Time Frame
    from anesthesia induction to 30 minutes after remove the laryngeal mask
    Title
    Hemodynamic changes :Heart rate(HR)
    Description
    Heart rate(HR) during perioperative period
    Time Frame
    from anesthesia induction to 30 minutes after remove the laryngeal mask
    Title
    Incidence of adverse reactions: Severe sinus bradycardia
    Description
    Severe sinus bradycardia: HR<40 times/min during perioperative period
    Time Frame
    from anesthesia induction to 30 minutes after remove the laryngeal mask
    Title
    Incidence of adverse reactions: bronchospasm
    Description
    Perioperative bronchospasm
    Time Frame
    from anesthesia induction to 30 minutes after remove the laryngeal mask
    Title
    Laryngeal mask airway (LMA) removal time
    Description
    Duration from the end of anesthetics infusion to LMA removal
    Time Frame
    Duration from the end of anesthetics infusion to LMA removal

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria 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 Exclusion criteria 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiumei Song, M.D.
    Phone
    13969050425
    Email
    ssm801117@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jinwan Guo, Master
    Organizational Affiliation
    Qianfoshan Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ling Dong, M.D.
    Organizational Affiliation
    Qianfoshan Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yang Liu, M.D.
    Organizational Affiliation
    Qianfoshan Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Liang Guo, M.D.
    Organizational Affiliation
    Qianfoshan Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    demographic data,statistical data,study protocol
    IPD Sharing Time Frame
    after 2024/1/1
    IPD Sharing Access Criteria
    undecided
    Citations:
    PubMed Identifier
    34508397
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33235101
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34582903
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24998108
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33434497
    Citation
    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.
    Results Reference
    background

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