Effect of Esmolol on Perioperative Stress Reaction

January 20, 2023 updated by: Xiumei Song

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

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: esmolol group
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
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.
Other Names:
  • Esmolol hydrochloride
Placebo Comparator: Saline solution
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
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.
Other Names:
  • 0.9% sodium chloride injection solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in plasma norepinephrine levels
Time Frame: up to 30 minutes after beginning of operation
level of Norepinephrine
up to 30 minutes after beginning of operation
Changes in plasma epinephrine levels
Time Frame: up to 30 minutes after beginning of operation
level of epinephrine
up to 30 minutes after beginning of operation
Changes in plasma cortisol levels
Time Frame: up to 30 minutes after beginning of operation
level of cortisol
up to 30 minutes after beginning of operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic changes ：Systolic blood pressure（SBP ）
Time Frame: from anesthesia induction to 30 minutes after remove the laryngeal mask
Systolic blood pressure (SBP ) during perioperative period
from anesthesia induction to 30 minutes after remove the laryngeal mask
Hemodynamic changes ：Diastolic blood pressure（ DBP）
Time Frame: from anesthesia induction to 30 minutes after remove the laryngeal mask
Diastolic blood pressure（ DBP） during perioperative period
from anesthesia induction to 30 minutes after remove the laryngeal mask
Hemodynamic changes ：Heart rate（HR）
Time Frame: from anesthesia induction to 30 minutes after remove the laryngeal mask
Heart rate（HR） during perioperative period
from anesthesia induction to 30 minutes after remove the laryngeal mask
Incidence of adverse reactions: Severe sinus bradycardia
Time Frame: from anesthesia induction to 30 minutes after remove the laryngeal mask
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
Time Frame: from anesthesia induction to 30 minutes after remove the laryngeal mask
Perioperative bronchospasm
from anesthesia induction to 30 minutes after remove the laryngeal mask
Laryngeal mask airway (LMA) removal time
Time Frame: Duration from the end of anesthetics infusion to LMA removal
Duration from the end of anesthetics infusion to LMA removal
Duration from the end of anesthetics infusion to LMA removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiumei Song

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXLL-KY-2022(107)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

demographic data，statistical data，study protocol

IPD Sharing Time Frame

after 2024/1/1

IPD Sharing Access Criteria

undecided

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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