Airway Stress Response
Conditions
Keywords
Airway Stress Response, Extubation, Dexmedetomidine, Labetalol, Hemodynamic Stability, Hypertension, Craniotomy
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.
Interventions
DRUGDexmedetomidine
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.
DRUGLabetalol
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Extubation Assessed Using a Standardized 5-Point Scale | Within the first 5 minutes after extubation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation Level Post-Extubation | Within 10 minutes after extubation | Sedation level will be evaluated using the Richmond Agitation-Sedation Scale (RASS) within 10 minutes following extubation. The RASS is a validated tool for assessing the level of consciousness in patients, with scores ranging from +4 (combative) to -5 (unarousable). A score of 0 indicates an alert and calm state, while negative scores represent increasing levels of sedation and positive scores reflect agitation. |
| Mean Arterial Pressure (MAP) Variation from Baseline | From baseline (pre-infusion) to 5 minutes post-extubation | Mean Arterial Pressure (MAP) will be recorded at baseline (pre-drug administration), during drug infusion, immediately post-extubation, and at 1, 3, and 5 minutes after extubation. The goal is to evaluate the extent to which MAP deviates from baseline values following administration of either dexmedetomidine or labetalol. MAP stability is defined as values maintained within ±20% of baseline. This outcome will be used to assess the effectiveness of each drug in attenuating hemodynamic responses associated with extubation in hypertensive patients undergoing craniotomy. |
| Heart Rate Variation from Baseline | From baseline (pre-infusion) to 5 minutes post-extubation. | Heart rate (HR) will be recorded at baseline (prior to administration of the study drug), during drug infusion, immediately after extubation, and at 1, 3, and 5 minutes post-extubation. The primary objective is to compare heart rate responses between the dexmedetomidine and labetalol groups and determine how effectively each drug maintains HR within ±20% of the baseline. This outcome will help evaluate the efficacy of both interventions in attenuating the sympathetic response to extubation in hypertensive patients undergoing craniotomy. |
| Incidence of Adverse Events During and After Extubation | From initiation of drug infusion to 10 minutes post-extubation | Adverse events will be monitored and documented from the start of study drug administration until 10 minutes post-extubation. Events of interest include bradycardia (heart rate \< 50 bpm), hypotension (MAP decrease \> 20% from baseline), respiratory depression, laryngospasm, severe coughing, nausea, vomiting, or any other clinically significant complication. All adverse events will be recorded, classified by severity, and managed according to standard anesthetic protocols. This outcome aims to compare the safety profiles of dexmedetomidine and labetalol in the context of emergence from anesthesia in hypertensive patients undergoing craniotomy. |
Countries
Egypt
Outcome results
None listed