To Measure Systolic Blood Pressure PostintubationPhase 4NCT06374017
Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response
A Phase 4 study testing Normal saline, Lidocaine, dexmetomidine in people with To Measure Systolic Blood Pressure Postintubation, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Many studies discussed attenuating stress response by various measures but to the interest of our study , No one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs , Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- To Measure Systolic Blood Pressure Postintubation
- What is being tested?
- Normal saline, Lidocaine, dexmetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2024to 10 Jan 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • ASA I,II
- Age 18-60y
- Patients scheduled for any operations under general anesthesia and needs endotracheal intubation using direct laryngoscopy in the operating theatre.
Who cannot join
- • Uncontrolled high blood pressure > 160/100 heart disease in the form of ischemic heart disease and severe valvular disease.
- Patients with the history of allergy to lidocaine or dexmedetomidine.
- ASA III \& IV.
- Patients refuse to share in this study
- Suspected difficult intubation that needs more than 2 trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect of Topical Lidocaine Spray Versus Dexmedetomidine Spray on Suppression of Stress Response to Laryngoscopy and Endotracheal Intubation: a Randomized Controlled Study
Many studies discussed attenuating stress response by various measures but to the interest of our study , No one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs ,
Read the detailed description
This study will be conducted in the operating theatres of Cairo university hospitals.
Patients undergoing any surgery under general anesthesia and needs endotracheal intubation using direct laryngoscopy will be assigned to one of the three groups:
Group C: will receive 5ml of normal saline sprayed via long nostril syringe into oropharynx, the vocal cords and tracheobronchial tree 5 minutes before intubation Group L: : will receive 5ml of lidocaine 2% (100mg) sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation Group D: : will receive dexmedetomidine (1 μg/kg) diluted in 5ml normal saline sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation.
- Being tested
- Normal saline, Lidocaine, dexmetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal saline, Lidocaine, dexmetomidineDrug
The study drug of each group will be sprayed into oropharynx, the vocal cords and tracheal tree 3 minutes after induction of anesthesia and 5 minutes before intubation.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | Group C: will receive 5ml of normal saline sprayed via long nostril syringe into oropharynx, the vocal cords and tracheobronchial tree 5 minutes before intubation Receives: Drug: Normal saline, Lidocaine, dexmetomidine |
| Group L | Active comparator | : : will receive 5ml of lidocaine 2% (100mg) sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation Receives: Drug: Normal saline, Lidocaine, dexmetomidine |
| Group D | Active comparator | will receive dexmedetomidine (1 μg/kg) diluted in 5ml normal saline sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation. Receives: Drug: Normal saline, Lidocaine, dexmetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure systolic blood pressure immediately after intubation.
Using invasive blood pressure monitoring
Measured: Immediately after endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start20 Apr 2024
- Primary completion30 Dec 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Measure Systolic Blood Pressure PostintubationStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mahmoud Mohamed, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374017
- Sponsor's protocol ID
- N-258-2023
- Status last verified
- Mar 2025
- First submitted
- 11 Apr 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Topical Lidocaine Spray Versus Dexmedetomidine Spray on Suppression of Stress Response to Laryngoscopy and Endotracheal Intubation: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06374017
- Acronym / sponsor ID
- N-258-2023
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 18 Apr 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.
Many studies discussed attenuating stress response by various measures but to the interest of our study , No one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs ,
Detailed description
This study will be conducted in the operating theatres of Cairo university hospitals.
Patients undergoing any surgery under general anesthesia and needs endotracheal intubation using direct laryngoscopy will be assigned to one of the three groups:
Group C: will receive 5ml of normal saline sprayed via long nostril syringe into oropharynx, the vocal cords and tracheobronchial tree 5 minutes before intubation Group L: : will receive 5ml of lidocaine 2% (100mg) sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation Group D: : will receive dexmedetomidine (1 μg/kg) diluted in 5ml normal saline sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Drug: Normal saline, Lidocaine, dexmetomidineGroup C: will receive 5ml of normal saline sprayed via long nostril syringe into oropharynx, the vocal cords and tracheobronchial tree 5 minutes before intubation |
| Group L | Active comparator | Drug: Normal saline, Lidocaine, dexmetomidine: : will receive 5ml of lidocaine 2% (100mg) sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation |
| Group D | Active comparator | Drug: Normal saline, Lidocaine, dexmetomidinewill receive dexmedetomidine (1 μg/kg) diluted in 5ml normal saline sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • ASA I,II
Key exclusion criteria (5 listed)
- • Uncontrolled high blood pressure > 160/100 heart disease in the form of ischemic heart disease and severe valvular disease.
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 |
|---|---|---|
| Normal saline, Lidocaine, dexmetomidineThe study drug of each group will be sprayed into oropharynx, the vocal cords and tracheal tree 3 minutes after induction of anesthesia and 5 minutes before intubation. | Drug | Group C, Group D, Group L |
Primary outcome
To measure systolic blood pressure immediately after intubation.
Time frame: Immediately after endotracheal intubation
Using invasive blood pressure monitoring
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 2 Apr 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal saline, Lidocaine, dexmetomidine in people with To Measure Systolic Blood Pressure Postintubation, run by Kasr El Aini Hospital at 1 site 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 3 inclusion and 5 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 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
To measure systolic blood pressure immediately after intubation. (time frame: Immediately after endotracheal intubation). 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 2 Apr 2025.