Dexmedetomidine vs Labetalol for Airway Stress in Hypertensive Craniotomy Patients

NCT07034898 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: FMASU MS /806/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Stress Response

Keywords

Airway Stress Response; Extubation; Dexmedetomidine; Labetalol; Hemodynamic Stability; Hypertension; Craniotomy

Outcome Measures

Primary Outcomes (1)

• Quality of Extubation Assessed Using a Standardized 5-Point Scale

  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.

  Within the first 5 minutes after extubation

Secondary Outcomes (4)

• Sedation Level Post-Extubation

  Within 10 minutes after extubation

• Mean Arterial Pressure (MAP) Variation from Baseline

  From baseline (pre-infusion) to 5 minutes post-extubation

• Heart Rate Variation from Baseline

  From baseline (pre-infusion) to 5 minutes post-extubation.

• Incidence of Adverse Events During and After Extubation

  From initiation of drug infusion to 10 minutes post-extubation

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Labetalol Group

EXPERIMENTAL

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.

Drug: Labetalol

Interventions

Dexmedetomidine 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.

Also known as: Precedex, DEX, Alpha-2 agonist

Dexmedetomidine Group

Labetalol 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.

Also known as: Normodyne, Trandate, LAB, Alpha/Beta blocker

Labetalol Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Hypertension

Interventions

Dexmedetomidine; Adrenergic alpha-2 Receptor Agonists; Labetalol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 24, 2025
• Study Start: April 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before 3/2026
• Access Criteria: Free

Locations

EG (1)