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

NCT07651657 | Not Yet Recruiting

• 1 other identifier: Mayo3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Dexmedetomidine; Lignocaine; Tracheal extubation; Hemodynamic response; Randomized controlled trial; Resource limited populations

Outcome Measures

Primary Outcomes (1)

• 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.

  [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

  [Baseline, after drug administration(before extubation), 1 minute, 3 minutes, 5 minutes and 10 minutes post-extubation]

Study Arms (2)

Group A (Dexmedetomidine)

EXPERIMENTAL

Procedure: Tracheal Extubation

Group B (Lignocaine)

ACTIVE COMPARATOR

Procedure: Tracheal Extubation

Interventions

Tracheal Extubation PROCEDURE

Effect of Dexmedetomidine on hemodynamic responses during tracheal extubation.

Group A (Dexmedetomidine)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Hospital Lahore: lead

Study Sites (1)

Mayo hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

Airway Extubation

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Investigative Techniques

Study Officials

• Murva Javid

  Mayo Hospital Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murva Javid

CONTACT

+923313232475; murvajavid@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

PA (1)