Cardiac SurgeryPhase 4hemodynamicsNCT06395727
Effect of Topical Airway Block on Hemodynamic Stability Post Induction of Anaesthesia in Cardiac Surgeries
A Phase 4 study testing Fentanyl and Lidocain in people with Cardiac Surgery, run by Ain Shams University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Fentanyl and Lidocain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Apr 2024to 28 Dec 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Undergoing elective cardiac surgery.
- Age: above 18
Who cannot join
- • 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
Show all 9Show fewer
- Presence of aortic dissection
- EF<40 %
- Severe mitral valve stenosis or severe aortic valve stenosis
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiac Surgery
- Being tested
- Fentanyl, Lidocain
- Keywords
- cardiac, airway block, lidocaine spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
traditional fentanyl dose
LidocainDrug
lidocaine nebuliser and lidocaine spray targeting difficult swallowing
| Study group | Role | What they receive |
|---|---|---|
| • Traditional balanced anaesthesia (control group) | Experimental | Analgesia will be offered by fentanyl 3-5 mic/kg in induction Receives: 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. Receives: Drug: Lidocain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from induction to skin incision
Secondary outcomes (2)
Total doses of vasoactive drugs used
total dose of vaso active drugs used to support hemodynamics
Measured: from induction to skin incision
Total doses of opioids used
total dose of opioids used from induction to icu transferal
Measured: through out the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start25 Apr 2024
- Primary completion13 Nov 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395727
- Sponsor's protocol ID
- FMASU R57/2024
- Acronym
- hemodynamics
- Status last verified
- Mar 2024
- First submitted
- 29 Apr 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Airway Block on Hemodynamic Stability Post Induction of Anaesthesia in Cardiac Surgeries
- ClinicalTrials.gov ID
- NCT06395727
- Acronym / sponsor ID
- hemodynamics / FMASU R57/2024
- Conditions
- Cardiac Surgery
- Keywords
- cardiac, airway block, lidocaine spray
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| • Traditional balanced anaesthesia (control group) | Experimental | Drug: FentanylAnalgesia will be offered by fentanyl 3-5 mic/kg in induction |
| • Airway topical anaesthesia | Experimental | Drug: LidocainPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Undergoing elective cardiac surgery.
Key exclusion criteria (9 listed)
- • Pregnant or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyltraditional fentanyl dose | Drug | • Traditional balanced anaesthesia (control group) |
| Lidocainlidocaine nebuliser and lidocaine spray targeting difficult swallowing | Drug | • Airway topical anaesthesia |
Primary outcome
Hemodynamic instability
Time frame: from induction to skin incision
Hemodynamic instability before induction, before intubation and 30 seconds, 1 minute and 2 minutes after intubation then every 5 minutes till skin incision.
2 secondary outcomes
Total doses of vasoactive drugs used
Time frame: from induction to skin incision
Total doses of opioids used
Time frame: through out the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl and Lidocain in people with Cardiac Surgery, run by Ain Shams University at 2 sites in Egypt.
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 2 inclusion and 9 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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hemodynamic instability (time frame: from induction to skin incision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2025.