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Effect of Esmolol on Perioperative Stress Reaction

Sponsor
Xiumei Song (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05694585
Collaborator
(none)
46
Enrollment
2
Arms
10.9
Anticipated Duration (Months)

Study Details

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 .

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Continuous Infusion of Esmolol on Perioperative Stress Reaction in Patients Undergoing Airway Intervention
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.
Other Names:
  • Esmolol hydrochloride

    		•
    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
    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.
    Other Names:
  • 0.9% sodium chloride injection solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in plasma norepinephrine levels [up to 30 minutes after beginning of operation]

      level of Norepinephrine

    2. Changes in plasma epinephrine levels [up to 30 minutes after beginning of operation]

      level of epinephrine

    3. Changes in plasma cortisol levels [up to 30 minutes after beginning of operation]

      level of cortisol

    Secondary Outcome Measures

    1. Hemodynamic changes ：Systolic blood pressure（SBP ） [from anesthesia induction to 30 minutes after remove the laryngeal mask]

      Systolic blood pressure (SBP ) during perioperative period

    2. Hemodynamic changes ：Diastolic blood pressure（ DBP） [from anesthesia induction to 30 minutes after remove the laryngeal mask]

      Diastolic blood pressure（ DBP） during perioperative period

    3. Hemodynamic changes ：Heart rate（HR） [from anesthesia induction to 30 minutes after remove the laryngeal mask]

      Heart rate（HR） during perioperative period

    4. Incidence of adverse reactions: Severe sinus bradycardia [from anesthesia induction to 30 minutes after remove the laryngeal mask]

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

    5. Incidence of adverse reactions: bronchospasm [from anesthesia induction to 30 minutes after remove the laryngeal mask]

      Perioperative bronchospasm

    6. Laryngeal mask airway (LMA) removal time [Duration from the end of anesthetics infusion to LMA removal]

      Duration from the end of anesthetics infusion to LMA removal

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Xiumei Song

    Investigators

    • Principal Investigator: Jinwan Guo, Master, Qianfoshan Hospital
    • Principal Investigator: Ling Dong, M.D., Qianfoshan Hospital
    • Principal Investigator: Yang Liu, M.D., Qianfoshan Hospital
    • Principal Investigator: Liang Guo, M.D., Qianfoshan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Xiumei Song, Associate chief physician, Qianfoshan Hospital
    ClinicalTrials.gov Identifier:
    NCT05694585
    Other Study ID Numbers:
    • YXLL-KY-2022(107)
    First Posted:
    Jan 23, 2023
    Last Update Posted:
    Jan 23, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiumei Song, Associate chief physician, Qianfoshan Hospital
    continuous infusion
    Additional relevant MeSH terms:
    Airway Obstruction
    Fractures, Stress
    Esmolol

    Study Results

    No Results Posted as of Jan 23, 2023