Hemodynamic Responses During Tracheal ExtubationNCT07651657
Comparative Study About The Effect Of Dexmedetomidine Vs Lignocaine On Hemodynamic Stability During Tracheal Extubation, Especially In Resource Limited Populations
A study testing Tracheal Extubation in people with Hemodynamic Responses During Tracheal Extubation and Peri-extubation Hypertension, run by Mayo Hospital Lahore at 1 site in Pakistan.
Trial summary
This randomized, double-blind controlled trial aims to compare the effectiveness of intravenous dexmedetomidine (0.5 µg/kg) and lignocaine (1.5 mg/kg) in attenuating hemodynamic responses during tracheal extubation in adult patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemodynamic Responses During Tracheal Extubation, Peri-extubation Hypertension, Peri-extubation Tachycardia
- What is being tested?
- Tracheal Extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2026to Dec 2026
- Phase
- Interventional
- 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
- 60 adult patients, aged between 18 and 50 years. •ASA I patients, undergoing elective procedures, requiring general anaesthesia and intubation. •Normotensive patients ( systolic BP<140 mm Hg and diastolic BP <90 mm Hg) before surgery.
Who cannot join
- Patients with known hypersensitivity to dexmedetomidine or lignocaine. •Pregnant or breastfeeding women. •Emergency cases. •Patients with anticipated difficult airway. • History of hypertension or cardiac arrhythmias.
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
Mayo hospital Lahore
Lahore, Punjab Province, 54000
Murva Javid, +923313232475, murvajavid@gmail.com
About this study
Official title: Comparative Study About The Effect Of Dexmedetomidine Vs Lignocaine On Hemodynamic Stability During Tracheal Extubation, Especially In Resource Limited Populations: A Randomized Controlled Trial
This randomized, double-blind controlled trial aims to compare the effectiveness of intravenous dexmedetomidine (0.5 µg/kg) and lignocaine (1.5 mg/kg) in attenuating hemodynamic responses during tracheal extubation in adult patients undergoing elective surgery. Tracheal extubation is commonly associated with sympathetic stimulation, leading to tachycardia, hypertension, and airway reflex responses, which may increase perioperative risk. A total of 60 ASA I patients aged 18-50 years will be randomly allocated in a 1:1 ratio; one receiving dexmedetomidine and the other lignocaine, administered intravenously 10 minutes prior to extubation. A structured proforma will be used to record hemodynamic parameters, including heart rate, systolic and diastolic blood pressure, and mean arterial pressure at baseline, before extubation, during extubation, and at 1, 3, 5, and 10 minutes post-extubation. The primary objective is to evaluate and compare the ability of these agents to attenuate hemodynamic responses during extubation. The findings of this study are expected to help identify a safe and effective strategy for smoother extubation and improved hemodynamic stability, particularly in resource-limited healthcare settings.
- Conditions
- Hemodynamic Responses During Tracheal Extubation, Peri-extubation Hypertension, Peri-extubation Tachycardia
- Being tested
- Tracheal Extubation
- Keywords
- Dexmedetomidine, Lignocaine, Tracheal extubation, Hemodynamic response, Randomized controlled trial, Resource limited populations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal ExtubationProcedure or surgery
Effect of Dexmedetomidine on hemodynamic responses during tracheal extubation.
Tracheal ExtubationProcedure or surgery
Effect of Lignocaine on hemodynamic responses during tracheal extubation.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Dexmedetomidine) | Experimental | Not described Receives: Procedure: Tracheal Extubation |
| Group B (Lignocaine) | Active comparator | Not described Receives: Procedure: Tracheal Extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mean arterial pressure (MAP) during tracheal extubation
Mean arterial pressure (MAP) measured at baseline, after drug administration, 1 minute post- extubation, 3 minutes post-extubation, 5 minutes post-extubation and 10 minutes post-extubation, comparing the effect of dexmedetomidine 0.5 microgram/kg versus lignocaine 1.5 mg/kg.
Measured: [Baseline, after drug administration(before extubation), 1 minute, 3 minutes, 5 minutes and 10 minutes post-extubation]
Secondary outcomes (1)
Heart rate response during tracheal extubation
Comparison of changes in heart rate (beats per minute) between the dexmedetomidine and lignocaine groups at baseline (T0), before extubation (T1), during extubation (T2), and at 1, 3, 5, and 10 minutes after extubation (T3-T6). The outcome will be expressed as mean heart rate and mean change from baseline at each time point.
Measured: [Baseline, after drug administration(before extubation), 1 minute, 3 minutes, 5 minutes and 10 minutes post-extubation]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic Responses During Tracheal ExtubationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Hospital Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeel Ahmed, Mayo Hospital Lahore
- Investigators
- Murva Javid, Principal investigator, Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651657
- Sponsor's protocol ID
- Mayo3
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study About The Effect Of Dexmedetomidine Vs Lignocaine On Hemodynamic Stability During Tracheal Extubation, Especially In Resource Limited Populations: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07651657
- Acronym / sponsor ID
- Mayo3
- Conditions
- Hemodynamic Responses During Tracheal Extubation, Peri-extubation Hypertension, Peri-extubation Tachycardia
- Keywords
- Dexmedetomidine, Lignocaine, Tracheal extubation, Hemodynamic response, Randomized controlled trial, Resource limited populations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo Hospital LahoreUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jun 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 randomized, double-blind controlled trial aims to compare the effectiveness of intravenous dexmedetomidine (0.5 µg/kg) and lignocaine (1.5 mg/kg) in attenuating hemodynamic responses during tracheal extubation in adult patients undergoing elective surgery. Tracheal extubation is commonly associated with sympathetic stimulation, leading to tachycardia, hypertension, and airway reflex responses, which may increase perioperative risk. A total of 60 ASA I patients aged 18-50 years will be randomly allocated in a 1:1 ratio; one receiving dexmedetomidine and the other lignocaine, administered intravenously 10 minutes prior to extubation. A structured proforma will be used to record hemodynamic parameters, including heart rate, systolic and diastolic blood pressure, and mean arterial pressure at baseline, before extubation, during extubation, and at 1, 3, 5, and 10 minutes post-extubation. The primary objective is to evaluate and compare the ability of these agents to attenuate hemodynamic responses during extubation. The findings of this study are expected to help identify a safe and effective strategy for smoother extubation and improved hemodynamic stability, particularly in resource-limited healthcare settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Dexmedetomidine) | Experimental | Procedure: Tracheal Extubation |
| Group B (Lignocaine) | Active comparator | Procedure: Tracheal Extubation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 60 adult patients, aged between 18 and 50 years. •ASA I patients, undergoing elective procedures, requiring general anaesthesia and intubation. •Normotensive patients ( systolic BP<140 mm Hg and diastolic BP <90 mm Hg) before surgery.
Key exclusion criteria (1 listed)
- Patients with known hypersensitivity to dexmedetomidine or lignocaine. •Pregnant or breastfeeding women. •Emergency cases. •Patients with anticipated difficult airway. • History of hypertension or cardiac arrhythmias.
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 |
|---|---|---|
| Tracheal ExtubationEffect of Dexmedetomidine on hemodynamic responses during tracheal extubation. | Procedure or surgery | Group A (Dexmedetomidine) |
| Tracheal ExtubationEffect of Lignocaine on hemodynamic responses during tracheal extubation. | Procedure or surgery | Group A (Dexmedetomidine), Group B (Lignocaine) |
Primary outcome
Comparison of mean arterial pressure (MAP) during tracheal extubation
Time frame: [Baseline, after drug administration(before extubation), 1 minute, 3 minutes, 5 minutes and 10 minutes post-extubation]
Mean arterial pressure (MAP) measured at baseline, after drug administration, 1 minute post- extubation, 3 minutes post-extubation, 5 minutes post-extubation and 10 minutes post-extubation, comparing the effect of dexmedetomidine 0.5 microgram/kg versus lignocaine 1.5 mg/kg.
1 secondary outcome
Heart rate response during tracheal extubation
Time frame: [Baseline, after drug administration(before extubation), 1 minute, 3 minutes, 5 minutes and 10 minutes post-extubation]
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 16 Jun 2026.
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.
Murva Javid principal investigator
Mayo Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheal Extubation in people with Hemodynamic Responses During Tracheal Extubation and Peri-extubation Hypertension, run by Mayo Hospital Lahore 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: opening soon, as of the sponsor's last update on 16 Jun 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.
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 Murva Javid (+923313232475, murvajavid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of mean arterial pressure (MAP) during tracheal extubation (time frame: [Baseline, after drug administration(before extubation), 1 minute, 3 minutes, 5 minutes and 10 minutes post-extubation]). 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 16 Jun 2026.