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

NCT06395727 | Completed Phase 4

• 1 other identifier: FMASU R57/2024
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiac Surgery

Keywords

cardiac, airway block, lidocaine spray

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total doses of vasoactive drugs used

  from induction to skin incision

• Total doses of opioids used

  through out the operation

Study Arms (2)

• Traditional balanced anaesthesia (control group)

EXPERIMENTAL

Analgesia will be offered by fentanyl 3-5 mic/kg in induction

Drug: Fentanyl

• Airway topical anaesthesia

EXPERIMENTAL

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

Interventions

Fentanyl DRUG

traditional fentanyl dose

• Traditional balanced anaesthesia (control group)

Lidocain DRUG

lidocaine nebuliser and lidocaine spray targeting difficult swallowing

• Airway topical anaesthesia

Eligibility Criteria

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

You may qualify if:

• Undergoing elective cardiac surgery.
• Age: above 18

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Abdallah

Cairo, 02, Egypt

Location

Abdallah Mahmoud Zaki Soudi

Cairo, Egypt

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Anaesthesia will be provided according to the hospital protocol in respect to preoperative investigations, fasting hours and intra-operative monitoring and drugs. All patients will be monitored by ECG, pulse oximeter and non-invasive blood pressure monitoring before receiving 2 mg midazolam for sedation before radial artery catheter insertion. After arterial catheter insertion, patients will be allocated to two groups, the first one (TBA group) will receive fentanyl traditional dose 3-5 mic/kg during induction. The second group will sit and receive lidocaine 2% nebulizer and then lidocaine 10 % oral application till achieving difficult swallowing. Then patient will lie, and induction will be done by fentanyl at a dose max 1 mic/kg. Then, both groups will receive general anaesthesia induction. Hemodynamic parameters will be recorded before induction, before intubation, 30 seconds, 1 minute and 2 minutes after intubation then every 5 minutes till skin incision.

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: April 25, 2024
• Primary Completion: November 13, 2024
• Study Completion: December 28, 2024
• Last Updated: September 11, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months

Locations

EG (2)