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NCT Number: NCT04744480

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;
  • 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;

Treatment and study plan

The combined topical anesthesia induction group

Procedure

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.

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. The frequency and types of vasoactive drugs used.

    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.

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

  2. The incidence of arrhythmias.

    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.

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

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

    Time frame: Preoperative, intraoperative

    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﹪

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

    Time frame: Preoperative, intraoperative

    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.

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

    Time frame: Intraoperative

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

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

    Time frame: Intraoperative

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

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

    Time frame: Intraoperative

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

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

    Time frame: Intraoperative

    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.

  9. The number of patients with postoperative hoarseness.

    Time frame: Three days after the surgery

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

  10. The number of patients with postoperative sore throat.

    Time frame: Three days after the surgery

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

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 9, 2021
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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