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Effect of Esmolol on Perioperative Stress Reaction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05694585
Recruitment Status : Not yet recruiting
First Posted : January 23, 2023
Last Update Posted : January 23, 2023
Sponsor:
Information provided by (Responsible Party):
Xiumei Song, Qianfoshan Hospital

Study Description
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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
Esmolol Stress Reaction Airway Obstruction Catecholamine; Overproduction Drug: Esmolol Drug: saline 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : February 1, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 0.9% sodium chloride injection solution


Outcome Measures
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Primary Outcome Measures :
  1. Changes in plasma norepinephrine levels [ Time Frame: up to 30 minutes after beginning of operation ]
    level of Norepinephrine

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

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


Secondary Outcome Measures :
  1. Hemodynamic changes ：Systolic blood pressure（SBP ） [ Time Frame: 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） [ Time Frame: from anesthesia induction to 30 minutes after remove the laryngeal mask ]
    Diastolic blood pressure（ DBP） during perioperative period

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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05694585


Contacts
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Contact: Xiumei Song, M.D. 13969050425 ssm801117@163.com

Sponsors and Collaborators
Xiumei Song
Investigators
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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
More Information
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Publications:

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Responsible Party: Xiumei Song, Associate chief physician, Qianfoshan Hospital
ClinicalTrials.gov Identifier: NCT05694585    
Other Study ID Numbers: YXLL-KY-2022(107)
First Posted: January 23, 2023    Key Record Dates
Last Update Posted: January 23, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: demographic data，statistical data，study protocol
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: after 2024/1/1
Access Criteria: undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiumei Song, Qianfoshan Hospital:
continuous infusion
Additional relevant MeSH terms:
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Airway Obstruction
Fractures, Stress
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Fractures, Bone
Wounds and Injuries
Esmolol
 Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs