Dexmedetomidine vs Labetalol for Airway Stress in Hypertensive Craniotomy Patients
Launched by AIN SHAMS UNIVERSITY · Jun 15, 2025
Trial Information
Current as of September 11, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study is a randomized, double-blind comparison of two drugs—dexmedetomidine and labetalol—given during surgery to help control airway stress and stabilize blood pressure and heart rate when the breathing tube is removed after craniotomy in people with hypertension. The main goal is to see which drug leads to a smoother extubation within the first 5 minutes after the tube is removed, using a simple 5-point scale (lower scores are better). Secondary checks include how alert or sedated people are right after extubation, how much their blood pressure and heart rate change in the first few minutes, and whether any safety problems occur.
Who can participate: adults aged 30–60 with diagnosed hypertension who are planned for elective craniotomy under general anesthesia and have ASA II health status, able to give informed consent. People are excluded if they have more serious health problems (ASA III/IV), uncontrolled conditions, bleeding risks or anticoagulant use, allergies to either drug, emergency surgery, pregnancy, certain heart rhythm issues, or inability to participate. About 60 participants will be randomly assigned to receive either dexmedetomidine (0.5 mcg/kg) or labetalol (0.5 mg/kg) over 10 minutes before extubation, at Ain Shams University in Cairo, and the trial is currently enrolling by invitation with completion expected around August 31, 2025. Safety monitoring includes watching for very slow heart rate, significant blood pressure drops, breathing problems, severe coughing, nausea, and other adverse events.
Gender
ALL
Eligibility criteria
- 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
About Ain Shams University
Ain Shams University, established in Cairo, Egypt, is a prestigious higher education institution renowned for its commitment to academic excellence and research innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise in various medical and scientific disciplines to advance healthcare through rigorous research initiatives. With a focus on ethical practices and adherence to regulatory standards, Ain Shams University aims to contribute to the development of new therapies and improve patient outcomes, fostering collaboration among researchers, healthcare professionals, and industry partners in the pursuit of medical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cairo, Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported