TachycardiaPhase 2/3NCT07385040
Comparison of IV Lignocain and IV Dexmedetomidine for Attenuation of Laryngoscopic Stress Response to Direct Laryngoscopy
A Phase 2/3 study testing Intravenous Dexmedetomidine infusion and Intravenous Lignocain in people with Tachycardia and Hypertension, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
Trial summary
Hemodymanic stress response to direct laryngoscopy and endotracheal intubation is a known phenomenon that occur in almost every patient undergoing general anesthesia before surgical procedure. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tachycardia, Hypertension, Mean Arterial Pressure
- What is being tested?
- Intravenous Dexmedetomidine infusion and Intravenous Lignocain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Apr 2023to 31 Dec 2023
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing general anesthesia for any elective surgery Having ASA 1 or 2 Having mallapatti 1 or 2 Having BMI in between 18-30 kg/m2
Who cannot join
- Lack of consent Anticipated difficult airway Pregnancy Sensitivity to either drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intravenous Lignocain and Intravenous Dexmedetomidine for Attenuation of Hemodynamic Stress Response to Direct Laryngoscopy and Endotracheal Intubation
Hemodymanic stress response to direct laryngoscopy and endotracheal intubation is a known phenomenon that occur in almost every patient undergoing general anesthesia before surgical procedure. This response leads to sudden rise in heart rate and blood pressure which may cause serious complications in compromised patients having cardiovascular diseases. There are certain drugs which are used to blunt this response and to prevent the life threatening complications. Intravenous Lignocain is commonly used drug to blunt the laryngoscopic response in our setup. Intravenous Dexmedetomidine is a newer and rarely used drug to prevent stress response to direct laryngoscopy and endotracheal intubation. This study aims to compare the efficacy of both the drugs to provide better control of complications like Arrythmias, stroke and cardiovascular instability.
- Conditions
- Tachycardia, Hypertension, Mean Arterial Pressure
- Being tested
- Intravenous Dexmedetomidine infusion, Intravenous Lignocain
- Keywords
- Direct laryngoscopy, Hemodynamic stress response, Lignocaine, Dexmedetomidine
- Medical subject headings
- Tachycardia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Dexmedetomidine infusionDrug
Dexmedetomidine infusion with dose of 10mics/kg given 10min before induction
Intravenous LignocainDrug
Intravenous ligoncain 1.5mg/kg given 90sec before induction.
| Study group | Role | What they receive |
|---|---|---|
| Group L | Active comparator | Group L received IV Lignocain 1.5mg/kg before induction. Receives: Drug: Intravenous Lignocain |
| Group D | Active comparator | Group D received IV Dexmedetomidine infusion 10mics/ kg over 10min before induction Receives: Drug: Intravenous Dexmedetomidine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic stress response
Rise in Heart rate and mean arterial pressure
Measured: 1 minute and 3 minute 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 posted3 Feb 2026
- Study start13 Apr 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 TachycardiaStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded, randomised control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Maryam, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Investigators
- Maryam Maryam, Principal investigator, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385040
- Sponsor's protocol ID
- ERC-000072/SMBBIT/Aproval/2023
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mahiswar AP, Dubey PK, Ranjan A. Comparison between dexmedetomidine and fentanyl bolus in attenuating the stress response to laryngoscopy and tracheal intubation: a randomized double-blind trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):103-109. doi: 10.1016/j.bjane.2021.02.060. Epub 2021 May 14.
PubMed 34000325
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenous Lignocain and Intravenous Dexmedetomidine for Attenuation of Hemodynamic Stress Response to Direct Laryngoscopy and Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT07385040
- Acronym / sponsor ID
- ERC-000072/SMBBIT/Aproval/2023
- Conditions
- Tachycardia, Hypertension, Mean Arterial Pressure
- Keywords
- Direct laryngoscopy, Hemodynamic stress response, Lignocaine, Dexmedetomidine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of TraumaUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Feb 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.
Hemodymanic stress response to direct laryngoscopy and endotracheal intubation is a known phenomenon that occur in almost every patient undergoing general anesthesia before surgical procedure. This response leads to sudden rise in heart rate and blood pressure which may cause serious complications in compromised patients having cardiovascular diseases. There are certain drugs which are used to blunt this response and to prevent the life threatening complications. Intravenous Lignocain is commonly used drug to blunt the laryngoscopic response in our setup. Intravenous Dexmedetomidine is a newer and rarely used drug to prevent stress response to direct laryngoscopy and endotracheal intubation. This study aims to compare the efficacy of both the drugs to provide better control of complications like Arrythmias, stroke and cardiovascular instability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded, randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Group L | Active comparator | Drug: Intravenous LignocainGroup L received IV Lignocain 1.5mg/kg before induction. |
| Group D | Active comparator | Drug: Intravenous Dexmedetomidine infusionGroup D received IV Dexmedetomidine infusion 10mics/ kg over 10min before induction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing general anesthesia for any elective surgery Having ASA 1 or 2 Having mallapatti 1 or 2 Having BMI in between 18-30 kg/m2
Key exclusion criteria (1 listed)
- Lack of consent Anticipated difficult airway Pregnancy Sensitivity to either drug
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 |
|---|---|---|
| Intravenous Dexmedetomidine infusionDexmedetomidine infusion with dose of 10mics/kg given 10min before induction | Drug | Group D |
| Intravenous LignocainIntravenous ligoncain 1.5mg/kg given 90sec before induction. | Drug | Group L |
Primary outcome
Hemodynamic stress response
Time frame: 1 minute and 3 minute after endotracheal intubation
Rise in Heart rate and mean arterial pressure
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 3 Feb 2026.
- Background: PubMed 34000325Mahiswar AP, Dubey PK, Ranjan A. Comparison between dexmedetomidine and fentanyl bolus in attenuating the stress response to laryngoscopy and tracheal intubation: a randomized double-blind trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):103-109. doi: 10.1016/j.bjane.2021.02.060. Epub 2021 May 14.
- J NTR Univ Health Sci 2015;4:86-90Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Maryam Maryam principal investigator
Shaheed Mohtarma Benazir Bhutto Institue of Trauma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intravenous Dexmedetomidine infusion and Intravenous Lignocain in people with Tachycardia and Hypertension, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma 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 1 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 3 Feb 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stress response (time frame: 1 minute and 3 minute after endotracheal intubation). 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 NCT07385040, 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 3 Feb 2026.