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Enrolling by invitation Phase 4

Dexmedetomidine vs Labetalol for Airway Stress in Hypertensive Craniotomy Patients

NCT07034898 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 4
Started
2025-04-01
Last updated
2025-06-24

Condition(s) studied

Airway Stress Response

Investigational drug(s) / intervention(s)

Dexmedetomidine →Labetalol →

Dexmedetomidine: Participants in this arm will receive dexmedetomidine at a dose of 0.5 mcg/kg, diluted with normal saline to a total volume of 50 mL. The solution will be administered intravenously via a syringe pump at an infusion rate of 300 mL/hour, completing over 10 minutes immediately prior to extubation.

Labetalol: Participants in this arm will receive labetalol at a dose of 0.5 mg/kg, diluted with normal saline to a total volume of 50 mL. The solution will be administered intravenously via a syringe pump at an infusion rate of 300 mL/hour, completing over 10 minutes immediately prior to extubation.

Study summary

This randomized trial compares dexmedetomidine and labetalol in controlling airway and hemodynamic stress during extubation in hypertensive patients undergoing craniotomy. Outcomes include extubation quality, vital signs, sedation, and adverse effects.

Eligibility

Sex
ALL
Min age
30 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 30 and 60 years American Society of Anesthesiologists (ASA) physical status II Diagnosed hypertension Scheduled for elective craniotomy under general anesthesia Able and willing to provide informed consent Exclusion Criteria: * ASA physical status III or IV Uncontrolled comorbidities (e.g., diabetes mellitus) Coagulopathy or current use of anticoagulant or antiplatelet therapy Known allergy or hypersensitivity to dexmedetomidine or labetalol Emergency craniotomy Pregnant or breastfeeding women Patients with a history of severe cardiac arrhythmias Inability to provide informed consent

Primary outcome measure(s)

  • Quality of Extubation Assessed Using a Standardized 5-Point Scale — Within the first 5 minutes after extubation
    Extubation quality will be assessed immediately after extubation using a standardized 5-point scale, where: 1. = No cough, smooth extubation 2. = Minimal coughing (1-2 times), smooth extubation 3. = Moderate coughing (3-4 times) 4. = Severe coughing (5-10 times) or difficulty breathing 5. = Poor extubation, very uncomfortable, forced breathing (e.g., laryngospasm or coughing \>10 times) A lower score indicates better extubation quality. The outcome will be evaluated by a blinded observer within the first 5 minutes post-extubation.

Trial sites (1)

FacilityCityRegionStatus
Ain Shams University Cairo Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07034898 on ClinicalTrials.gov ↗ ← All trials in Egypt