- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07611890
Dexmedetomidine vs Lignocaine for Reducing Intubation-Induced Hemodynamic Responses in Cardiac Surgery: A Randomized Controlled Trial
May 21, 2026 updated by: Namrah Zujaj, Rawalpindi Institute of Cardiology
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
70
Phase
- Phase 4
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: Namrah Zujaj, MBBS
- Phone Number: +92 305 2636980
- Email: zujajnamrah20@gmail.com
Study Locations
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Pakistan, 46000
- Recruiting
- Rawalpindi Institute of Cardiology
-
Contact:
- Asma Shabbir, MBBS,FCPS
- Phone Number: +92 333 5161142
- Email: Research@ricrwp.edu.pk
-
-
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:
American Society of Anesthesiologists (ASA) physical status III-IV. Patients who are at risk of cardiovascular events
Exclusion Criteria:
- 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.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group Dexmed
|
0.5 Mcg/kg of Dexmedetomidine will be given 10 minutes before laryngoscopy
|
|
Active Comparator: Group Lignocaine
|
Patients will be given 1.5 mg/kg of Lignocaine 3 minutes before laryngoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Qudsia Anjum, MBBS,FCPS, Rawalpindi Institute of Cardiology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 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 (Actual)
May 21, 2026
Primary Completion (Estimated)
August 21, 2026
Study Completion (Estimated)
August 21, 2026
Study Registration Dates
First Submitted
May 21, 2026
First Submitted That Met QC Criteria
May 21, 2026
First Posted (Actual)
May 28, 2026
Study Record Updates
Last Update Posted (Actual)
May 28, 2026
Last Update Submitted That Met QC Criteria
May 21, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIC/RERC/13/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Hospital Ethical Committee doesnt allow
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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