Dexmedetomidine vs Labetalol for Airway Stress in Hypertensive Craniotomy Patients
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: Dexmedetomidine, Labetalol.
- Who it may be relevant to
- Registry conditions: Airway Stress Response. Basic parameters: 30 years — 60 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
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Comparative Study of Dexmedetomidine Versus Labetalol in Attenuating Airway Stress Response in Hypertensive Patients Undergoing Craniotomy
Overview
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.
Detailed description
A. Preoperative Settings:
Patients will undergo standard pre-anesthetic assessment, including review of medical history, fasting status, and laboratory investigations. Eligibility will be confirmed based on inclusion and exclusion criteria. After obtaining informed consent, patients will be randomly assigned into two groups using a computer-generated randomization table and sealed envelopes.
B. Intraoperative and Postoperative Settings:
All patients will receive standardized general anesthesia with continuous monitoring. Following completion of surgery and while still under anesthesia, the study drug (either dexmedetomidine or labetalol) will be administered over 10 minutes. Extubation will be performed thereafter.
Hemodynamic parameters including arterial blood pressure and heart rate will be recorded at baseline, during drug administration, and at specific intervals post-extubation. Extubation quality will be assessed using a five-point scale, and sedation levels using the Richmond Agitation-Sedation Scale. Adverse events such as hypotension, bradycardia, or respiratory issues will be documented and managed as per protocol.
This structured approach aims to evaluate which agent provides better control of stress responses during emergence from anesthesia in hypertensive patients undergoing craniotomy.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- Quality of Extubation Assessed Using a Standardized 5-Point Scale [Time frame: Within the first 5 minutes after extubation]
Secondary outcome measures (4)
- Sedation Level Post-Extubation [Time frame: Within 10 minutes after extubation]
- Mean Arterial Pressure (MAP) Variation from Baseline [Time frame: From baseline (pre-infusion) to 5 minutes post-extubation]
- Heart Rate Variation from Baseline [Time frame: From baseline (pre-infusion) to 5 minutes post-extubation.]
- Incidence of Adverse Events During and After Extubation [Time frame: From initiation of drug infusion to 10 minutes post-extubation]
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
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
Egypt · 1 center
- Ain Shams University — Cairo
Identifiers
NCT: NCT07034898 · FMASU MS /806/2024