Airway Stress ResponsePhase 4NCT07034898
Dexmedetomidine vs Labetalol for Airway Stress in Hypertensive Craniotomy Patients
A Phase 4 study testing Dexmedetomidine and Labetalol in people with Airway Stress Response, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Airway Stress Response
- What is being tested?
- Dexmedetomidine and Labetalol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 31 Aug 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Comparative Study of Dexmedetomidine Versus Labetalol in Attenuating Airway Stress Response in Hypertensive Patients Undergoing Craniotomy
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.
Read the detailed description
- 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.
- 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
- Being tested
- Dexmedetomidine, Labetalol
- Keywords
- Airway Stress Response, Extubation, Dexmedetomidine, Labetalol, Hemodynamic Stability, Hypertension, Craniotomy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex, DEX, Alpha-2 agonist
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.
LabetalolDrug
Also called Normodyne, Trandate, LAB, Alpha/Beta blocker
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- = No cough, smooth extubation
- = Minimal coughing (1-2 times), smooth extubation
- = Moderate coughing (3-4 times)
- = Severe coughing (5-10 times) or difficulty breathing
- = 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.
Measured: Within the first 5 minutes after extubation
Secondary outcomes (4)
Sedation Level Post-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.
Measured: Within 10 minutes after extubation
Mean Arterial Pressure (MAP) Variation from Baseline
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.
Measured: From baseline (pre-infusion) to 5 minutes post-extubation
Heart Rate Variation from Baseline
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.
Measured: From baseline (pre-infusion) to 5 minutes post-extubation.
Incidence of Adverse Events During and After 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.
Measured: From initiation of drug infusion to 10 minutes post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Apr 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Stress ResponseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034898
- Sponsor's protocol ID
- FMASU MS /806/2024
- Status last verified
- Feb 2025
- First submitted
- 15 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study of Dexmedetomidine Versus Labetalol in Attenuating Airway Stress Response in Hypertensive Patients Undergoing Craniotomy
- ClinicalTrials.gov ID
- NCT07034898
- Acronym / sponsor ID
- FMASU MS /806/2024
- Conditions
- Airway Stress Response
- Keywords
- Airway Stress Response, Extubation, Dexmedetomidine, Labetalol, Hemodynamic Stability, Hypertension, Craniotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: DexmedetomidineA 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 | Experimental | Drug: LabetalolA 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Precedex, DEX, Alpha-2 agonistParticipants 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. | Drug | Dexmedetomidine Group |
| LabetalolAlso: Normodyne, Trandate, LAB, Alpha/Beta blockerParticipants 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. | Drug | Labetalol Group |
Primary outcome
Quality of Extubation Assessed Using a Standardized 5-Point Scale
Time frame: 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.
4 secondary outcomes
Sedation Level Post-Extubation
Time frame: Within 10 minutes after extubation
Mean Arterial Pressure (MAP) Variation from Baseline
Time frame: From baseline (pre-infusion) to 5 minutes post-extubation
Heart Rate Variation from Baseline
Time frame: From baseline (pre-infusion) to 5 minutes post-extubation.
Incidence of Adverse Events During and After Extubation
Time frame: From initiation of drug infusion to 10 minutes post-extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: Yes. All data will be shared once study is completed
Related trials for Airway Stress Response
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Labetalol in people with Airway Stress Response, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Extubation Assessed Using a Standardized 5-Point Scale (time frame: Within the first 5 minutes after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.