Effect of Esmolol on Perioperative Stress Reaction

NCT05694585 | Unknown Phase 4

• 1 other identifier: YXLL-KY-2022(107)
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Esmolol; Stress Reaction; Airway Obstruction; Catecholamine; Overproduction

Keywords

continuous infusion

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• Hemodynamic changes ：Systolic blood pressure（SBP ）

  from anesthesia induction to 30 minutes after remove the laryngeal mask

• Hemodynamic changes ：Diastolic blood pressure（ DBP）

  from anesthesia induction to 30 minutes after remove the laryngeal mask

• Hemodynamic changes ：Heart rate（HR）

  from anesthesia induction to 30 minutes after remove the laryngeal mask

• Incidence of adverse reactions: Severe sinus bradycardia

  from anesthesia induction to 30 minutes after remove the laryngeal mask

• Incidence of adverse reactions: bronchospasm

  from anesthesia induction to 30 minutes after remove the laryngeal mask

Study Arms (2)

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.

Drug: Esmolol

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.

Drug: saline

Interventions

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.

Also known as: Esmolol hydrochloride

esmolol group

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.

Also known as: 0.9% sodium chloride injection solution

Saline solution

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical Status I to III.;
• Body mass index (BMI): 20-30 kg/m2;
• Elective airway intervention under general anesthesia with jet ventilation，duration of operation less than 2hs;
• Sign informed consent for clinical trial

You may not qualify if:

• The patient and his or her family refused to participate in the study;
• Severe respiratory or/cardiovascular or/ neurological disease, or/ hepatic or/renal dysfunction
• Those who are allergic to the drugs used in this study;
• Psychiatric history or with unstable mental state;
• Patients with atrioventricular block
• Patients with history of asthma
• Patients now treated with β-adrenergic receptor blockers
• Patients participating in other clinical trial

Sponsors & Collaborators

• Xiumei Song: lead

Related Publications (5)

• 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.

  PMID: 34508397 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.

  PMID: 33235101 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.

  PMID: 34582903 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.

  PMID: 24998108 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.

  PMID: 33434497 BACKGROUND

MeSH Terms

Conditions

Fractures, Stress; Airway Obstruction

Interventions

esmolol; Sodium Chloride

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jinwan Guo, Master

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

• Ling Dong, M.D.

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

• Yang Liu, M.D.

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

• Liang Guo, M.D.

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiumei Song, M.D.

CONTACT

13969050425; ssm801117@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 23, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after 2024/1/1
• Access Criteria: undecided