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Not yet recruiting NCT07651657

Comparative Study About The Effect Of Dexmedetomidine Vs Lignocaine On Hemodynamic Stability During Tracheal Extubation, Especially In Resource Limited Populations

No phase Interventional Hemodynamic Responses During Tracheal Extubation Peri-extubation Hypertension Peri-extubation Tachycardia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tracheal Extubation, Tracheal Extubation.
Who it may be relevant to
Registry conditions: Hemodynamic Responses During Tracheal Extubation, Peri-extubation Hypertension, Peri-extubation Tachycardia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Procedure Tracheal Extubation
    Effect of Dexmedetomidine on hemodynamic responses during tracheal extubation.
  • Procedure Tracheal Extubation
    Effect of Lignocaine on hemodynamic responses during tracheal extubation.

Primary outcome measures

  • 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]]
Secondary outcome measures (1)
  • 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]]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Mayo hospital Lahore — Lahore

Identifiers

NCT: NCT07651657 · Mayo3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗