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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| esmolol group | Experimental | 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 solution | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esmolol | Drug | 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. |
| 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 |
| 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） |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiumei Song, M.D. | Contact | 13969050425 | ssm801117@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinwan Guo, Master | Qianfoshan Hospital | Principal Investigator |
| Ling Dong, M.D. | Qianfoshan Hospital | Principal Investigator |
| Yang Liu, M.D. |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34508397 | Background | 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. | |
| 33235101 | Background | 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. |
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demographic data，statistical data，study protocol
after 2024/1/1
undecided
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| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| C036604 | esmolol |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
|
| saline | Drug | 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. |
|
|
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 |
| Qianfoshan Hospital |
| Principal Investigator |
| Liang Guo, M.D. | Qianfoshan Hospital | Principal Investigator |
| 34582903 | Background | 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. |
| 24998108 | Background | 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. |
| 33434497 | Background | 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. |
| D012140 |
| Respiratory Tract Diseases |
| D017670 |
| Sodium Compounds |