Effect of Esmolol on Perioperative Stress Reaction

Airway Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05694585
• Other study ID #: YXLL-KY-2022(107)
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Qianfoshan Hospital
• Contact: Xiumei Song, M.D.
• Phone: 13969050425
• Email: ssm801117[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 ß-adrenergic receptor blockers

8. Patients participating in other clinical trial

Related Conditions & MeSH terms

• Airway Obstruction
• Catecholamine; Overproduction
• Fractures, Stress
• Stress Reaction

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiumei Song

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma norepinephrine levels	level of Norepinephrine	up to 30 minutes after beginning of operation
Primary	Changes in plasma epinephrine levels	level of epinephrine	up to 30 minutes after beginning of operation
Primary	Changes in plasma cortisol levels	level of cortisol	up to 30 minutes after beginning of operation
Secondary	Hemodynamic changes :Systolic blood pressure(SBP )	Systolic blood pressure (SBP ) during perioperative period	from anesthesia induction to 30 minutes after remove the laryngeal mask
Secondary	Hemodynamic changes :Diastolic blood pressure( DBP)	Diastolic blood pressure( DBP) during perioperative period	from anesthesia induction to 30 minutes after remove the laryngeal mask
Secondary	Hemodynamic changes :Heart rate(HR)	Heart rate(HR) during perioperative period	from anesthesia induction to 30 minutes after remove the laryngeal mask
Secondary	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
Secondary	Incidence of adverse reactions: bronchospasm	Perioperative bronchospasm	from anesthesia induction to 30 minutes after remove the laryngeal mask
Secondary	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