- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07651657
Comparative Study About The Effect Of Dexmedetomidine Vs Lignocaine On Hemodynamic Stability During Tracheal Extubation, Especially In Resource Limited Populations
June 11, 2026 updated by: Adeel Ahmed, Mayo Hospital Lahore
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Murva Javid
- Phone Number: +923313232475
- Email: murvajavid@gmail.com
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Mayo hospital Lahore
-
Contact:
- Murva Javid
- Phone Number: +923313232475
- Email: murvajavid@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (Dexmedetomidine)
|
Effect of Dexmedetomidine on hemodynamic responses during tracheal extubation.
Effect of Lignocaine on hemodynamic responses during tracheal extubation.
|
|
Active Comparator: Group B (Lignocaine)
|
Effect of Dexmedetomidine on hemodynamic responses during tracheal extubation.
Effect of Lignocaine on hemodynamic responses during tracheal extubation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
[Baseline, after drug administration(before extubation), 1 minute, 3 minutes, 5 minutes and 10 minutes post-extubation]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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]
|
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.
|
[Baseline, after drug administration(before extubation), 1 minute, 3 minutes, 5 minutes and 10 minutes post-extubation]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Murva Javid, Mayo hospital Lahore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
June 11, 2026
First Submitted That Met QC Criteria
June 11, 2026
First Posted (Actual)
June 16, 2026
Study Record Updates
Last Update Posted (Actual)
June 16, 2026
Last Update Submitted That Met QC Criteria
June 11, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mayo3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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