Effect of Topical Airway Block on Hemodynamic Stability Post Induction of Anaesthesia in Cardiac Surgeries (hemodynamics)

Opioids have always been the mainstay in management of patients during cardiac surgeries. Mega doses are often used to relieve stress of surgeries in highly labile patients with narrow hemodynamic threshold to keep the balance between oxygen demand and supply. Unfortunately, this is associated with hemodynamic instability and affect the fast-track pathway for extubation. Most of these doses are given in induction, so by blocking airway by non-invasive technique, this will help in the reduction in opioid doses and preventing risky hemodynamic instability during induction of anesthesia in these patients.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Drug: Fentanyl; Drug: Lidocain

Detailed Description

Efficient handling of cardiac patients in cardiac surgeries is not an easy task. Patients are labile and more liable than others to hemodynamic changes in response to anaesthetic drugs and unfortunately, these changes are not well tolerated. (Choudhury A et al., 2017)

Any Hemodynamic change can have a great impact on the oxygen delivery - demand balance and lead to more damage. Every step is critical, but induction is the most challenging representing the peak of the dynamicity. Any change could happen, either tachycardia, hypertension, or arrhythmia in response to intubation or hypotension after induction or during period of minimal stimulus. (Soleimani A et al., 2017)

Although the concept of opioid based anaesthesia was the gold standard in cardiac surgeries for decades as opioids lack the negative inotropic effects, their usage was shifted from the mega doses of long acting opioids to titrating doses of short acting ones as fentanyl that became the primary in use.(Grant MC et al., 2023) Trying to control stress response to intubation by higher doses of opioids increase the liability for post induction hypotension which occurs in nearly one fourth to one third of patients receiving general anaesthesia. (Chen B et al., 2021)

The stress response to intubation could be inhibited by blocking the sensory pathway and hence the reflex response. Targeting the superior laryngeal nerve (SLN) that innervate the base of the tongue, epiglottis, piriform fossa, and vallecula together with trans tracheal topical anaesthesia will reduce the stress response to intubation. Fortunately, it's not essential to master anatomical landmarks and invasive techniques to block the sensory pathway as gradual topical spraying of local anaesthesia over the airway mucosal surfaces will lead to nearly equivalent effect in a simpler way. (Pignot G et al., 2022)

Lidocaine is one of the most commonly used local anaesthetics. It is generally safe and available in multiple dosage forms (topical, I.V., nebulizer and spray) and concentrations. It has been widely used for several indications in general anaesthesia starting from just cough suppression and reduction of sore throat to modulation of the stress response to intubation. (Mikawa K et al., 1997) Using lidocaine either topical or by nebulizer is a well-established method to anesthetise airway and can be used safely in cardiac surgeries. (Choudhury A et al., 2017) Also, lidocaine topical airway block showed significant effect on reducing QT changes in patients undergoing cardiac surgeries if applied before intubation. (Bilgi M et al.,2020)

Therefore, authors have hypothesised that air way block may help in reducing the doses of opioids needed to control the stress response of intubation and hence to better management of patient. This can be simply done by topical airway block with non-invasive techniques that are both safe and applicable for practice.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Abdallah
  • Cairo, Egypt
    • Abdallah Mahmoud Zaki Soudi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Undergoing elective cardiac surgery.

  • Age: above 18

Exclusion Criteria:

• • Pregnant or breast-feeding women

  • Emergency surgery
  • Anticipated difficult airway
  • Allergy to any of the drugs used in the study
  • Cannot cooperate to complete topical anaesthesia (with mental disorders or unable to communicate)
  • Use of a left ventricular assist device, IAB or ECMO prior to surgery
  • Presence of aortic dissection
  • EF<40 %
  • Severe mitral valve stenosis or severe aortic valve stenosis

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: • Traditional balanced anaesthesia (control group); Analgesia will be offered by fentanyl 3-5 mic/kg in induction	Drug: Fentanyl; traditional fentanyl dose
Experimental: • Airway topical anaesthesia; Patient will be given lidocaine nebulizer (5 ml of lidocaine 2% with oxygen flow 8 l/m) after radial arterial catheter insertion that will be complemented by topical application of lidocaine spray 10 % not to exceed 200mg per dose on mouth with encouraging to move it in mouth then gargling with it before swallowing targeting reaching difficult swallowing.	Drug: Lidocain; lidocaine nebuliser and lidocaine spray targeting difficult swallowing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic instability	Hemodynamic instability before induction, before intubation and 30 seconds, 1 minute and 2 minutes after intubation then every 5 minutes till skin incision.	from induction to skin incision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total doses of vasoactive drugs used	total dose of vaso active drugs used to support hemodynamics	from induction to skin incision
Total doses of opioids used	total dose of opioids used from induction to icu transferal	through out the operation

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Actual): November 13, 2024
• Study Completion (Actual): December 28, 2024

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cardiac, airway block, lidocaine spray
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Fentanyl
• Other Study ID Numbers: FMASU R57/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: 6 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No