Laryngoscopic Stress ResponsePhase 4NCT07611890
Dexmedetomidine vs Lignocaine for Reducing Intubation-Induced Hemodynamic Responses in Cardiac Surgery: A Randomized Controlled Trial
A Phase 4 study testing IV dexmedetomidine and IV Lignocaine in people with Laryngoscopic Stress Response and Dexmedetomidine, run by Rawalpindi Institute of Cardiology at 1 site in Pakistan.
Trial summary
After confirming eligibility, written informed consent will be obtained by a trained team member who is not involved in assigning treatment or giving the study medication. Each participant will receive a unique study number to protect privacy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laryngoscopic Stress Response, Dexmedetomidine, Lignocaine
- What is being tested?
- IV dexmedetomidine and IV Lignocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 21 May 2026to 21 Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status III-IV. Patients who are at risk of cardiovascular events
Who cannot join
- Patients with known hypersensitivity to dexmedetomidine and Lignocaine.
- Patients on medications that could interfere with the study (e.g., beta-blockers, calcium channel blockers).
- Pregnant or lactating women.
- Patients with a history of airway anomalies or difficult intubation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Rawalpindi Institute of Cardiology
Rawalpindi, Punjab Province, 46000
Asma Shabbir, MBBS,FCPS, +92 333 5161142, Research@ricrwp.edu.pk
About this study
Official title: Comparison of Intravenous Dexmedetomidine and Lignocaine in Reducing Hemodynamic Responses During Laryngoscopy and Endotracheal Intubation In Patients Undergoing Cardiac Surgery at Rawalpindi Institute Of Cardiology- A Randomized Controlled Trial
After confirming eligibility, written informed consent will be obtained by a trained team member who is not involved in assigning treatment or giving the study medication. Each participant will receive a unique study number to protect privacy. Participants will be randomly assigned to receive one of the study medications using a chance-based method.The study medication will be administered through a vein before placement of the breathing tube. Blood pressure and pulse rate will be measured before the procedure and at several time points after the breathing tube is inserted.
Read the detailed description
After confirming eligibility, written informed consent will be obtained and each participant will be assigned a unique study ID to maintain confidentiality. Participants will be randomly allocated using a computer-generated random sequence implemented through the lottery method, with assignments placed in sealed opaque envelopes opened on the day of surgery. The study medication will be administered intravenously according to the study protocol before laryngoscopy and endotracheal intubation. Mean arterial pressure and heart rate will be recorded at baseline and at 1, 3, 5, and 10 minutes after intubation. Demographic information and study-related observations will be documented in a structured data collection form.
- Conditions
- Laryngoscopic Stress Response, Dexmedetomidine, Lignocaine
- Being tested
- IV dexmedetomidine, IV Lignocaine
- Keywords
- Laryngoscopic stress response, Dexmedetomidine, Lignocaine, Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV dexmedetomidineDrug
0.5 Mcg/kg of Dexmedetomidine will be given 10 minutes before laryngoscopy
IV LignocaineDrug
Patients will be given 1.5 mg/kg of Lignocaine 3 minutes before laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Group Dexmed | Active comparator | Not described Receives: Drug: IV dexmedetomidine |
| Group Lignocaine | Active comparator | Not described Receives: Drug: IV Lignocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure
Measured: It will be expressed in millimeters of mercury (mmHg) and measured using an arterial catheter immediately before intubation and then at 1,3,5 and 10 minutes after intubation.
Heart Rate
Measured: It will be expressed as number of heart beats per minute and measured using pulse oximeter immediately before intubation and then at 1,3,5 and 10 minutes after intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start21 May 2026
- Primary completion21 Aug 2026 (estimated)
- Study completion21 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laryngoscopic Stress ResponseStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Institute of Cardiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Namrah Zujaj, Rawalpindi Institute of Cardiology
- Investigators
- Qudsia Anjum, MBBS,FCPS, Study chair, Rawalpindi Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611890
- Sponsor's protocol ID
- RIC/RERC/13/25
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital Ethical Committee doesnt allow
Publications
Dube S, Gosavi K, Admane G. Comparative study of Dexmedetomidine, Lignocaine and their combination for the attenuation of hemodynamic response during laryngoscopy and intubation [Internet]. Indian J Clin Anaesth. 2022 [cited 2026 May 21];9(1):27-31. Available from: https://doi.org/10.18231/j.ijca.2022.007
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenous Dexmedetomidine and Lignocaine in Reducing Hemodynamic Responses During Laryngoscopy and Endotracheal Intubation In Patients Undergoing Cardiac Surgery at Rawalpindi Institute Of Cardiology- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07611890
- Acronym / sponsor ID
- RIC/RERC/13/25
- Conditions
- Laryngoscopic Stress Response, Dexmedetomidine, Lignocaine
- Keywords
- Laryngoscopic stress response, Dexmedetomidine, Lignocaine, Cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Rawalpindi Institute of CardiologyUniversity, hospital or other
- Study start
- 21 May 2026 (actual)
- Primary completion
- 21 Aug 2026 (estimated)
- Study completion
- 21 Aug 2026 (estimated)
- First posted
- 28 May 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.
After confirming eligibility, written informed consent will be obtained by a trained team member who is not involved in assigning treatment or giving the study medication. Each participant will receive a unique study number to protect privacy. Participants will be randomly assigned to receive one of the study medications using a chance-based method.The study medication will be administered through a vein before placement of the breathing tube. Blood pressure and pulse rate will be measured before the procedure and at several time points after the breathing tube is inserted.
Detailed description
After confirming eligibility, written informed consent will be obtained and each participant will be assigned a unique study ID to maintain confidentiality. Participants will be randomly allocated using a computer-generated random sequence implemented through the lottery method, with assignments placed in sealed opaque envelopes opened on the day of surgery. The study medication will be administered intravenously according to the study protocol before laryngoscopy and endotracheal intubation. Mean arterial pressure and heart rate will be recorded at baseline and at 1, 3, 5, and 10 minutes after intubation. Demographic information and study-related observations will be documented in a structured data collection form.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Dexmed | Active comparator | Drug: IV dexmedetomidine |
| Group Lignocaine | Active comparator | Drug: IV Lignocaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status III-IV. Patients who are at risk of cardiovascular events
Key exclusion criteria (4 listed)
- Patients with known hypersensitivity to dexmedetomidine and Lignocaine.
- Patients on medications that could interfere with the study (e.g., beta-blockers, calcium channel blockers).
- Pregnant or lactating women.
- Patients with a history of airway anomalies or 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 |
|---|---|---|
| IV dexmedetomidine0.5 Mcg/kg of Dexmedetomidine will be given 10 minutes before laryngoscopy | Drug | Group Dexmed |
| IV LignocainePatients will be given 1.5 mg/kg of Lignocaine 3 minutes before laryngoscopy | Drug | Group Lignocaine |
Primary outcome
Mean Arterial Pressure
Time frame: It will be expressed in millimeters of mercury (mmHg) and measured using an arterial catheter immediately before intubation and then at 1,3,5 and 10 minutes after intubation.
Heart Rate
Time frame: It will be expressed as number of heart beats per minute and measured using pulse oximeter immediately before intubation and then at 1,3,5 and 10 minutes after intubation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- BackgroundDube S, Gosavi K, Admane G. Comparative study of Dexmedetomidine, Lignocaine and their combination for the attenuation of hemodynamic response during laryngoscopy and intubation [Internet]. Indian J Clin Anaesth. 2022 [cited 2026 May 21];9(1):27-31. Available from: https://doi.org/10.18231/j.ijca.2022.007
- Individual participant dataSharing planned: No. Hospital Ethical Committee doesnt allow
Related trials for Laryngoscopic Stress Response
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Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy
Laryngoscopy, Hemodynamic Changes
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.
Qudsia Anjum, MBBS,FCPS study chair
Rawalpindi Institute of Cardiology
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 IV dexmedetomidine and IV Lignocaine in people with Laryngoscopic Stress Response and Dexmedetomidine, run by Rawalpindi Institute of Cardiology at 1 site in Pakistan.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 May 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Namrah Zujaj, MBBS (+92 305 2636980, zujajnamrah20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (time frame: It will be expressed in millimeters of mercury (mmHg) and measured using an arterial catheter immediately before intubation and then at 1,3,5 and 10 minutes after intubation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07611890, which also lists 1 linked publication.
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 28 May 2026.