Dexmedetomidine vs Labetalol for Airway Stress in Hypertensive Craniotomy Patients

Ain Shams University

Status and phase: Invitation-only; Phase 4

Conditions: Airway Stress Response

Treatments: Drug: Labetalol; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07034898

FMASU MS /806/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Dexmedetomidine Group

Experimental group

Description:

A 50 mL syringe pump containing 0.5 mcg/kg dexmedetomidine diluted with saline to 50 mL will be infused at 300 mL/hr to complete within 10 minutes, followed by extubation.

Treatment:

Drug: Dexmedetomidine

Labetalol Group

Experimental group

Description:

A 50 mL syringe pump containing 0.5 mg/kg labetalol diluted with saline to 50 mL will be infused at 300 mL/hr to complete within 10 minutes, followed by extubation.

Treatment:

Drug: Labetalol