LignocaineNCT07897578
Preoperative Nebulized Lignocaine Versus Nebulized Dexmedetomidine for Blunting the Pressor Response to Laryngoscopy and Intubation in Controlled Hypertensive Patients
A study testing Group D (Dexmedetomidine) and Group L (Lignocaine) in people with Lignocaine and Hypertensive Patients, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy of preoperative nebulized lignocaine versus nebulized dexmedetomidine for blunting the pressor response to laryngoscopy and intubation in patients with controlled hypertension under medical treatment. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Lignocaine, Hypertensive Patients, Dexmedetomidine
- What is being tested?
- Group D (Dexmedetomidine) and Group L (Lignocaine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2025to 30 Jun 2026
- Phase
- Interventional
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (45-70 years old)
- American Society of Anesthesiologists II
- Controlled hypertension (systolic blood pressure 140-160 mmHg, diastolic blood pressure 90-100 mmHg) on medication other than beta blocker.
- Scheduled for elective surgery requiring general anesthesia
Who cannot join
- History of heart failure, myocardial infarction, or arrhythmia
- Known allergy to local anesthetics or dexmedetomidine
- Chronic obstructive pulmonary disease or asthma
- Cardiac surgery
- Any possibility of difficult intubation
- Hepatic patients
Show all 9Show fewer
- On beta blockers, Ca channel blocker
- Renal disease
- Hyperthyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Preoperative Nebulized Lignocaine Versus Nebulized Dexmedetomidine for Blunting the Pressor Response to Laryngoscopy and Intubation in Controlled Hypertensive Patients
This study aims to compare the efficacy of preoperative nebulized lignocaine versus nebulized dexmedetomidine for blunting the pressor response to laryngoscopy and intubation in patients with controlled hypertension under medical treatment.
Read the detailed description
Securing the airway through endotracheal intubation is a fundamental responsibility of the anesthesiologist during general anesthesia. Direct laryngoscopy followed by intubation induces a stress response leading to hemodynamic changes, which are often transient, unpredictable, and variable .This response usually lasts for 30 seconds to 10 minutes The mechanisms underlying the hemodynamic responses are not completely understood, although they have been attributed to a reflex sympathetic discharge caused by stimulation of the upper respiratory tract .This pressor response is characterized by rapid increase in heart rate and blood pressure, potentially leading to arrhythmias and some other adverse events .
These effects are generally well tolerated by overall healthy patients but can be lethal to patients with pre-existing conditions such as coronary artery disease, hypertension , preeclampsia, and cerebrovascular pathologies such as tumors, aneurysms, or increased intracranial pressure .
Hypertensive patients are particularly vulnerable to these effects due to their pre-existing cardiovascular conditions. The pressor response is triggered by sympathetic stimulation during laryngoscopy, causing an average increase in blood pressure by 40-50% and heart rate by 20% . These changes, while often well-tolerated in healthy individuals, could be greater risk to those with hypertension, coronary artery disease .
To mitigate these adverse effects, various pharmacological agents have been explored. Among them, lignocaine, a widely used local anesthetic, has shown efficacy for attenuating the hemodynamic response to laryngoscopy and intubation . Nebulized lignocaine, in particular, offers a non-invasive method of administration with fewer side effects compared to intravenous delivery. On the other hand, dexmedetomidine, a selective alpha-2 adrenergic agonist, is gaining attention for its sedative, analgesic, and sympatholytic properties . Current studies suggest that nebulized dexmedetomidine may offer significant hemodynamic stability with fewer side effects than intravenous administration, making it a promising alternative, especially in hypertensive patients .
The choice of agent to blunt the pressor response in hypertensive patients is an important aspect of preoperative management, as minimizing cardiovascular strain during surgery can improve patient outcomes. Although numerous pharmacological agents have been studied, the ideal drug for preoperative use remains controversial.
In particular, the use of nebulized medications offers the advantage of targeted local delivery to the upper respiratory tract, which may result in more effective control of the sympathetic response with fewer systemic side effects. Both lignocaine and dexmedetomidine have shown promise in preliminary studies, yet comparative research specifically targeting controlled hypertensive patients remains limited.
This study aims to compare the efficacy of preoperative nebulized lignocaine versus nebulized dexmedetomidine for blunting the pressor response to laryngoscopy and intubation in patients with controlled hypertension under medical treatment.
- Conditions
- Lignocaine, Hypertensive Patients, Dexmedetomidine, Laryngoscopy
- Being tested
- Group D (Dexmedetomidine), Group L (Lignocaine)
- Keywords
- Lignocaine, Nebulized Dexmedetomidine, Hypertensive Patients, Laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group D (Dexmedetomidine)Drug
Group D (Dexmedetomidine): 25 patients will undergo nebulization with dexmedetomidine (1 μg/kg), mixed with normal saline to a total volume of 5 mL, administered via a nebulizer face mask at a continuous flow of 6 L/min of 100% oxygen over 10 minutes before the beginning of anesthesia.
Group L (Lignocaine)Drug
Group L (Lignocaine): 25 patients will undergo nebulization with 2% lignocaine (1.5 mg/kg) according to ideal body weight maximum 100 mg, mixed with normal saline to a total volume of 5 mL, administered via a nebulizer face mask at a continuous flow of 6 L/min of 100% oxygen over 10 minutes before the beginning of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group D (Dexmedetomidine) | Experimental | Group D (Dexmedetomidine): 25 patients will undergo nebulization with dexmedetomidine (1 μg/kg), mixed with normal saline to a total volume of 5 mL, administered via a nebulizer face mask at a continuous flow of 6 L/min of 100% oxygen over 10 minutes before the beginning of anesthesia. Receives: Drug: Group D (Dexmedetomidine) |
| Group L (Lignocaine) | Experimental | Group L (Lignocaine): 25 patients will undergo nebulization with 2% lignocaine (1.5 mg/kg) according to ideal body weight maximum 100 mg, mixed with normal saline to a total volume of 5 mL, administered via a nebulizer face mask at a continuous flow of 6 L/min of 100% oxygen over 10 minutes before the beginning of anesthesia. Receives: Drug: Group L (Lignocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of blunting Pressor Response to Laryngoscopy
Measured: 10 minutes post nebulization
Secondary outcomes (1)
Assessment of Heart rate change
Measured: 10 minutes post-intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start30 Dec 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LignocaineStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Ahmed Samy Shabaan Azzam, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897578
- Sponsor's protocol ID
- 36264MS848/2/25
- Status last verified
- Dec 2025
- First submitted
- 15 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: it will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preoperative Nebulized Lignocaine Versus Nebulized Dexmedetomidine for Blunting the Pressor Response to Laryngoscopy and Intubation in Controlled Hypertensive Patients
- ClinicalTrials.gov ID
- NCT07897578
- Acronym / sponsor ID
- 36264MS848/2/25
- Conditions
- Lignocaine, Hypertensive Patients, Dexmedetomidine, Laryngoscopy
- Keywords
- Lignocaine, Nebulized Dexmedetomidine, Hypertensive Patients, Laryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 27 Oct 2026 (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.
This study aims to compare the efficacy of preoperative nebulized lignocaine versus nebulized dexmedetomidine for blunting the pressor response to laryngoscopy and intubation in patients with controlled hypertension under medical treatment.
Detailed description
Securing the airway through endotracheal intubation is a fundamental responsibility of the anesthesiologist during general anesthesia. Direct laryngoscopy followed by intubation induces a stress response leading to hemodynamic changes, which are often transient, unpredictable, and variable .This response usually lasts for 30 seconds to 10 minutes The mechanisms underlying the hemodynamic responses are not completely understood, although they have been attributed to a reflex sympathetic discharge caused by stimulation of the upper respiratory tract .This pressor response is characterized by rapid increase in heart rate and blood pressure, potentially leading to arrhythmias and some other adverse events .
These effects are generally well tolerated by overall healthy patients but can be lethal to patients with pre-existing conditions such as coronary artery disease, hypertension , preeclampsia, and cerebrovascular pathologies such as tumors, aneurysms, or increased intracranial pressure .
Hypertensive patients are particularly vulnerable to these effects due to their pre-existing cardiovascular conditions. The pressor response is triggered by sympathetic stimulation during laryngoscopy, causing an average increase in blood pressure by 40-50% and heart rate by 20% . These changes, while often well-tolerated in healthy individuals, could be greater risk to those with hypertension, coronary artery disease .
To mitigate these adverse effects, various pharmacological agents have been explored. Among them, lignocaine, a widely used local anesthetic, has shown efficacy for attenuating the hemodynamic response to laryngoscopy and intubation . Nebulized lignocaine, in particular, offers a non-invasive method of administration with fewer side effects compared to intravenous delivery. On the other hand, dexmedetomidine, a selective alpha-2 adrenergic agonist, is gaining attention for its sedative, analgesic, and sympatholytic properties . Current studies suggest that nebulized dexmedetomidine may offer significant hemodynamic stability with fewer side effects than intravenous administration, making it a promising alternative, especially in hypertensive patients .
The choice of agent to blunt the pressor response in hypertensive patients is an important aspect of preoperative management, as minimizing cardiovascular strain during surgery can improve patient outcomes. Although numerous pharmacological agents have been studied, the ideal drug for preoperative use remains controversial.
In particular, the use of nebulized medications offers the advantage of targeted local delivery to the upper respiratory tract, which may result in more effective control of the sympathetic response with fewer systemic side effects. Both lignocaine and dexmedetomidine have shown promise in preliminary studies, yet comparative research specifically targeting controlled hypertensive patients remains limited.
This study aims to compare the efficacy of preoperative nebulized lignocaine versus nebulized dexmedetomidine for blunting the pressor response to laryngoscopy and intubation in patients with controlled hypertension under medical treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D (Dexmedetomidine) | Experimental | Drug: Group D (Dexmedetomidine)Group D (Dexmedetomidine): 25 patients will undergo nebulization with dexmedetomidine (1 μg/kg), mixed with normal saline to a total volume of 5 mL, administered via a nebulizer face mask at a continuous flow of 6 L/min of 100% oxygen over 10 minutes before the beginning of anesthesia. |
| Group L (Lignocaine) | Experimental | Drug: Group L (Lignocaine)Group L (Lignocaine): 25 patients will undergo nebulization with 2% lignocaine (1.5 mg/kg) according to ideal body weight maximum 100 mg, mixed with normal saline to a total volume of 5 mL, administered via a nebulizer face mask at a continuous flow of 6 L/min of 100% oxygen over 10 minutes before the beginning of anesthesia. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (45-70 years old)
- American Society of Anesthesiologists II
- Controlled hypertension (systolic blood pressure 140-160 mmHg, diastolic blood pressure 90-100 mmHg) on medication other than beta blocker.
- Scheduled for elective surgery requiring general anesthesia
Key exclusion criteria (9 listed)
- History of heart failure, myocardial infarction, or arrhythmia
- Known allergy to local anesthetics or dexmedetomidine
- Chronic obstructive pulmonary disease or asthma
- Cardiac surgery
- Any possibility of difficult intubation
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 |
|---|---|---|
| Group D (Dexmedetomidine)Group D (Dexmedetomidine): 25 patients will undergo nebulization with dexmedetomidine (1 μg/kg), mixed with normal saline to a total volume of 5 mL, administered via a nebulizer face mask at a continuous flow of 6 L/min of 100% oxygen over 10 minutes before the beginning of anesthesia. | Drug | Group D (Dexmedetomidine) |
| Group L (Lignocaine)Group L (Lignocaine): 25 patients will undergo nebulization with 2% lignocaine (1.5 mg/kg) according to ideal body weight maximum 100 mg, mixed with normal saline to a total volume of 5 mL, administered via a nebulizer face mask at a continuous flow of 6 L/min of 100% oxygen over 10 minutes before the beginning of anesthesia. | Drug | Group L (Lignocaine) |
Primary outcome
Assessment of blunting Pressor Response to Laryngoscopy
Time frame: 10 minutes post nebulization
1 secondary outcome
Assessment of Heart rate change
Time frame: 10 minutes post-intubation
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 27 Oct 2026.
- Individual participant dataSharing planned: Yes. it will be available if it needed
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group D (Dexmedetomidine) and Group L (Lignocaine) in people with Lignocaine and Hypertensive Patients, run by Tanta University 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 4 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 27 Oct 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Assessment of blunting Pressor Response to Laryngoscopy (time frame: 10 minutes post nebulization). 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 27 Oct 2026.