Effect of Esmolol on Perioperative Stress Reaction

Xiumei Song

Status and phase: Not yet enrolling; Phase 4

Conditions: Stress Reaction; Esmolol; Catecholamine; Overproduction; Airway Obstruction

Treatments: Drug: Esmolol; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05694585

YXLL-KY-2022(107)

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups, including a placebo group

esmolol group

Experimental group

Description:

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.

Treatment:

Drug: Esmolol

Saline solution

Placebo Comparator group

Description:

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.

Treatment:

Drug: saline