Airway Obstruction, Catecholamine; Overproduction, Esmolol, Stress Reaction
Conditions
Keywords
continuous infusion
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.
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.
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.
Sponsors
Xiumei Song
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in plasma norepinephrine levels | up to 30 minutes after beginning of operation | level of Norepinephrine |
| Changes in plasma epinephrine levels | up to 30 minutes after beginning of operation | level of epinephrine |
| Changes in plasma cortisol levels | up to 30 minutes after beginning of operation | level of cortisol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic changes ：Systolic blood pressure（SBP ） | from anesthesia induction to 30 minutes after remove the laryngeal mask | Systolic blood pressure (SBP ) during perioperative period |
| Hemodynamic changes ：Diastolic blood pressure（ DBP） | from anesthesia induction to 30 minutes after remove the laryngeal mask | Diastolic blood pressure（ DBP） during perioperative period |
| Hemodynamic changes ：Heart rate（HR） | from anesthesia induction to 30 minutes after remove the laryngeal mask | Heart rate（HR） during perioperative period |
| 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 |
| Incidence of adverse reactions: bronchospasm | from anesthesia induction to 30 minutes after remove the laryngeal mask | Perioperative bronchospasm |
| 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 |
Contacts
Primary ContactXiumei Song, M.D.
Outcome results
None listed