Clinical trial NCT05694585: Effect of Esmolol on Perioperative Stress Reaction
Official title: Effect of Continuous Infusion of Esmolol on Perioperative Stress Reaction in Patients Undergoing Airway Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Esmolol
Stress Reaction
Airway Obstruction
Catecholamine; Overproduction
Keywords: continuous infusion
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Changes in plasma norepinephrine levels
timeFrame: up to 30 minutes after beginning of operation
measure: Changes in plasma epinephrine levels
timeFrame: up to 30 minutes after beginning of operation
measure: Changes in plasma cortisol levels
timeFrame: up to 30 minutes after beginning of operation
Secondary outcomes:
measure: Hemodynamic changes ：Systolic blood pressure（SBP ）
timeFrame: from anesthesia induction to 30 minutes after remove the laryngeal mask
measure: Hemodynamic changes ：Diastolic blood pressure（ DBP）
timeFrame: from anesthesia induction to 30 minutes after remove the laryngeal mask
measure: Hemodynamic changes ：Heart rate（HR）
timeFrame: from anesthesia induction to 30 minutes after remove the laryngeal mask
measure: Incidence of adverse reactions: Severe sinus bradycardia
timeFrame: from anesthesia induction to 30 minutes after remove the laryngeal mask
measure: Incidence of adverse reactions: bronchospasm
timeFrame: from anesthesia induction to 30 minutes after remove the laryngeal mask
measure: Laryngeal mask airway (LMA) removal time
timeFrame: Duration from the end of anesthetics infusion to LMA removal
Other outcomes:
Locations:
Study officials:
affiliation: Qianfoshan Hospital
name: Jinwan Guo, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Qianfoshan Hospital
name: Ling Dong, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Qianfoshan Hospital
name: Yang Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Qianfoshan Hospital
name: Liang Guo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.