Dexmedetomidine vs Labetalol for Airway Stress in Hypertensive Craniotomy Patients

NCT ID: NCT07034898

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-08-31

Brief 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.

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.

Conditions

Airway Stress Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine Group

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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 Group

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.

Group Type: EXPERIMENTAL

Labetalol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Precedex; DEX; Alpha-2 agonist; Normodyne; Trandate; LAB; Alpha/Beta blocker

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MS /806/2024

Identifier Type: -

Identifier Source: org_study_id