Dexmedetomidine vs Labetalol for Airway Stress in Hypertensive Craniotomy Patients
- Registration Number
- NCT07034898
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexmedetomidine Group Dexmedetomidine 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. Labetalol Group Labetalol 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Ain Shams University
🇪🇬Cairo, Egypt
Ain Shams University🇪🇬Cairo, Egypt