Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06395727 |
| Other study ID # |
FMASU R57/2024 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
April 25, 2024 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
