Effect of Esmolol on Perioperative Stress Reaction

Study Overview
=================
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.

Official Title
-----------------
Effect of Continuous Infusion of Esmolol on Perioperative Stress Reaction in Patients Undergoing Airway Intervention

Conditions
-----------------
Esmolol, Stress Reaction, Airway Obstruction, Catecholamine; Overproduction

Intervention / Treatment
-----------------
* Drug: Esmolol
* Drug: saline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: esmolol group<br>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<br>* 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.<br>* Other names: Esmolol hydrochloride;|
| Placebo Comparator: Saline solution<br>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<br>* 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.<br>* Other names: 0.9% sodium chloride injection solution;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma norepinephrine levels | level of Norepinephrine | up to 30 minutes after beginning of operation | 
| Changes in plasma epinephrine levels | level of epinephrine | up to 30 minutes after beginning of operation | 
| Changes in plasma cortisol levels | level of cortisol | up to 30 minutes after beginning of operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic changes ：Systolic blood pressure（SBP ） | Systolic blood pressure (SBP ) during perioperative period | from anesthesia induction to 30 minutes after remove the laryngeal mask | 
| Hemodynamic changes ：Diastolic blood pressure（ DBP） | Diastolic blood pressure（ DBP） during perioperative period | from anesthesia induction to 30 minutes after remove the laryngeal mask | 
| Hemodynamic changes ：Heart rate（HR） | Heart rate（HR） during perioperative period | from anesthesia induction to 30 minutes after remove the laryngeal mask | 
| Incidence of adverse reactions: Severe sinus bradycardia | Severe sinus bradycardia: HR<40 times/min during perioperative period | from anesthesia induction to 30 minutes after remove the laryngeal mask | 
| Incidence of adverse reactions: bronchospasm | Perioperative bronchospasm | from anesthesia induction to 30 minutes after remove the laryngeal mask | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
continuous infusion