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AzTrials

Coronary Artery DiseaseNCT04744480

Effect of Topical Anesthesia on Hemodynamics During the Induction Period in Patients Undergo Cardiac Surgery.

A study testing The combined topical anesthesia induction group in people with Coronary Artery Disease and Valvular Heart Disease, run by Qianfoshan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the induction is to decrease stress response of endotracheal intubation. It is also important to keep hemodynamics stable during and after the induction period. Previous studies have shown that topical anesthesia can provide excellent superior supraglottic and subglottic local anesthetic effects and can… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
The combined topical anesthesia induction group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteChina
Study dates
5 Mar 2021to 27 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients scheduled to accept elective /major cardiac surgery;
  • Patients older than 18 years and younger than 85 years;
  • Patients of The American Society of Anesthesiologists ( ASA )Ⅱ - Ⅳ level grade;
  • Patients signed the informed consent form for the clinical study;

Who cannot join

  • Patients cannot cooperate to topical anesthesia;
  • Patients with a left cardiac assist device prior to surgery;
  • Patients with aortic dissection;
  • Patients with Intra Aortic Balloon Pump (IABP) prior to surgery;
  • Patients treated with Extracorporeal Membrane Oxygenation (ECMO) prior to surgery;
  • Patients with difficult airway;
Show all 10Show fewer
  • Patients with high sensitivity and hypersensitivity to lidocaine and tetracaine;
  • Patients with atrioventricular block;
  • Hemoglobin(Hb)<80g/L；
  • Patients who have participated in other clinical studies during the last 3 months;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Meng-Lv

    Jinan, Shandong, 250000

Other trials in China

About this study

Official title: Effect of Topical Anesthesia Combined With Intravenous Induction on Hemodynamics During the Induction Period in Patients Undergo Cardiac Surgery: a Randomized Controlled Study

The aim of the induction is to decrease stress response of endotracheal intubation. It is also important to keep hemodynamics stable during and after the induction period. Previous studies have shown that topical anesthesia can provide excellent superior supraglottic and subglottic local anesthetic effects and can significantly reduce the dosage of intravenous anesthetics. Therefore, it is significant to explore whether the combination of topical anesthesia and intravenous anesthetics could decrease the stress response of endotracheal intubation and keep hemodynamics stable during and after the induction period.

Read the detailed description

The routine anesthesia induction strategy for cardiac surgery is to decrease stress response during endotracheal intubation by using large doses of opioids. However, high doses of opioids often leads to persistent and recurrent hypotension in patients from the anesthesia induction period to the beginning of the surgery. Patients scheduled to accept cardiac surgery often have severe concomitant disease. Hemodynamic fluctuation might lead to disastrous events. Anesthesia induction for such patients should not only provide adequate depth of anesthesia to decrease the stress response of endotracheal intubation, but also make hemodynamics stable after tracheal intubation.

Being tested
The combined topical anesthesia induction group
Keywords
Topical anesthesia, Cardiac surgery, Hemodynamics, Induction period
Medical subject headings
Coronary Artery Disease, Heart Valve Diseases, Arrhythmias, Cardiac, Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The combined topical anesthesia induction groupProcedure or surgery

    The superior glottic mucosa would be anesthetized 3 times with a vaporizer before intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia，3-5ml 2% lidocaine would be used for supraglottic anesthesia, and 3ml 1% tetracaine would be used for subglottic anesthesia.

Study groups in NCT04744480
Study groupRoleWhat they receive
The combined topical anesthesia induction groupExperimentalThe superior glottic mucosa would be anesthetized 3 times with a vaporizer before intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia，3-5ml 2% lidocaine would be used for supraglottic anesthesia, and 3ml 1% tetracaine would be used for subglottic anesthesia.
Receives: Procedure: The combined topical anesthesia induction group
The routine induction groupNo interventionThe superior glottic mucosa would be anesthetized 3 times with a vaporizer before intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia.In the routine induction group，all procedures will be the same as those of the topical anesthesia group, The drug will be replaced with constant volume saline.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The area under the curve of baseline blood pressure

    The area under the curve (AUC) of blood pressure below baseline from the beginning of general anesthesia induction to the surgery beginning.

    Measured: From the beginning of general anesthesia induction(T1) to the surgery beginning(T2). T1 is when induction drug (midazolam) is administered. T2 is defined as the time of the skin incision. It will take up to 1hour or 2hours.

Secondary outcomes (10)

  1. The frequency and types of vasoactive drugs used.

    The frequency and types of vasoactive drugs used ,such as the use of norepinephrine and dopamine.

    Measured: From the beginning of general anesthesia induction(T1) to the surgery beginning(T2). T1 is when induction drug (midazolam) is administered. T2 is defined as the time of the skin incision. It will take up to 1hour or 2hours.

  2. The incidence of arrhythmias.

    The incidence of arrhythmias, such as atrioventricular block, atrial fibrillation, ventricular tachycardia and so on.

    Measured: From the beginning of general anesthesia induction(T1) to the surgery beginning(T2). T1 is when induction drug (midazolam) is administered. T2 is defined as the time of the skin incision. It will take up to 1hour or 2hours.

  3. cardiac systolic function:Left Ventricular Ejection Fraction (LVEF)

    Left ventricular ejection fraction is a reliable indicator of left ventricular systolic function. left ventricular ejection fraction (LVEF) (﹪)= stroke output (SV)/ left ventricular end-diastolic volume (LEDV)×100﹪

    Measured: Preoperative, intraoperative

  4. cardiac diastolic function:E/E' (the ratio of E peak and E') or E/A :(the ratio of E peak and A peak)

    E/A ratio, one of the main indicators for evaluating diastolic function, indicated normal diastolic function when E/A >1, and decreased diastolic function when E/A < 1.

    Measured: Preoperative, intraoperative

  5. cardiac output monitoring indicator: CO(cardiac output)

    CO＝Stroke Output (SV)× Heart Rate (HR).The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences.

    Measured: Intraoperative

  6. cardiac output monitoring indicator: SVV(stroke volume variation)

    The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences.

    Measured: Intraoperative

  7. cardiac output monitoring indicator: CI(cardiac index)

    CI＝CO/ Body Surface Area (BSA).The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences.

    Measured: Intraoperative

  8. cardiac output monitoring indicator: SVR (systemic vascular resistance)

    SVR＝60×(MAP-CVP)/CO. MAP: mean arterial pressure. CVP: central venous pressure.The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences.

    Measured: Intraoperative

  9. The number of patients with postoperative hoarseness.

    Hoarseness was classified as mild, moderate and severe according to the severity.

    Measured: Three days after the surgery

  10. The number of patients with postoperative sore throat.

    Sore throats can be evaluated using the Numeric Pain Scale (NRS) pain numerical score.

    Measured: Three days after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2021
  2. Study start5 Mar 2021
  3. Primary completion27 Apr 2021
  4. Study completion27 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04744480
Sponsor's protocol ID
TACTICS
Status last verified
May 2022
First submitted
24 Jan 2021
Last updated
2 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen TT, Lv M, Wang JH, Wei CS, Gu CP, Wang YL. Addition of topical airway anaesthesia to conventional induction techniques to reduce haemodynamic instability during the induction period in patients undergoing cardiac surgery: protocol for a randomised controlled study. BMJ Open. 2022 Jan 25;12(1):e053337. doi: 10.1136/bmjopen-2021-053337.

    PubMed 35078841

Questions about this trial

What is this clinical trial studying?

A study testing The combined topical anesthesia induction group in people with Coronary Artery Disease and Valvular Heart Disease, run by Qianfoshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The area under the curve of baseline blood pressure (time frame: From the beginning of general anesthesia induction(T1) to the surgery beginning(T2). T1 is when induction drug (midazolam) is administered. T2 is defined as the time of the skin incision. It will take up to 1hour or 2hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04744480, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.

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