Comparison of Dexmedetomidine and Fentanyl to Prevent Hemodynamic Response to Skull Pins Application

Study Overview
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Brief Summary
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To compare the effect between dexmedetomidine and fentanyl for controlling the hemodynamic response to skull pins application

Detailed Description
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A randomized, double-blinded controlled trial was conducted from September 2015 to September 2016 in Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Thailand. Sixty patients who underwent craniotomy with insertion of skull pin were randomly allocated into group A and B. After patients entered the operative room, blood pressure and heart rate were measured (T1) then repeated measurement again (T2) when started induction, intubation and infusion dexmedetomidine 1 µg/kg over 10 min infusion in group A whereas group B received normal saline. At 3 minutes before skull pin insertion (T3), patient in group B received a single bolus of fentanyl 1 µg/kg whereas group A received normal saline. Then hemodynamic responses were recorded and repeated again at one minute before skull pin insertion (T4). Blood pressure and heart rate were observed at the time of skull pin insertion (T5) then repeated every 1 minutes after skull pin application until 5 minutes (T6 - T10).

Official Title
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Comparison of Dexmedetomidine and Fentanyl to Prevent Hemodynamic Response to Skull Pins Application in Neurosurgery:Double Blind Randomized Controlled Trial

Conditions
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Hemodynamic Response, Skull Pins Application

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Fentanyl
* Drug: 0.9% normal saline
* Device: Skull pins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who scheduled for elective craniotomy under general anesthesia patient with American Society of Anesthesiologists physical status classification of I and II Exclusion Criteria: patients having body mass index more than 30 kg/m2, heart rate lower than 45 bpm, hypertension, ischemic heart disease, heart block, on beta adrenergic blockers, medication allergy including propofol, fentanyl, and dexmedetomidine.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, double-blinded controlled trial was conducted from September 2015 to September 2016 in Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Thailand. Sixty patients who underwent craniotomy with insertion of skull pin were randomly allocated into group A and B. After patients entered the operative room, blood pressure and heart rate were measured (T1) then repeated measurement again (T2) when started induction, intubation and infusion dexmedetomidine 1 µg/kg over 10 min infusion in group A whereas group B received normal saline. At 3 minutes before skull pin insertion (T3), patient in group B received a single bolus of fentanyl 1 µg/kg whereas group A received normal saline. Then hemodynamic responses were recorded and repeated again at one minute before skull pin insertion (T4). Blood pressure and heart rate were observed at the time of skull pin insertion (T5) then repeated every 1 minutes after skull pin application until 5 minutes (T6 - T10).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine (Group A)<br>In induction period, group A received dexmedetomidine 1 µg/kg diluted to 20 ml with 0.9% normal saline 10 minute through a syringe pump. Three minutes before application of skull pins, group A received infusion of 2 ml of 0.9% normal saline. | Drug: Dexmedetomidine<br>* Dexmedetomidine 1 µg/kg diluted to 20 ml with 0.9% normal saline was administration. If adverse events were occurred, the patient will receive rescue drugs.<br>* Other names: precedex;Drug: 0.9% normal saline<br>* 0.9% normal saline was use to dilute the study drugs<br>Device: Skull pins<br>* Skull pins were use to stabilized the patent' s head during surgery<br>* Other names: Mayfield;|
| Active Comparator: Fentanyl (group B)<br>In induction period, group B received 20ml of 0.9% normal saline.Three minutes before application of skull pins, group B received infusion of fentanyl 1 µg/kg diluted to 2 ml with 0.9% normal saline | Drug: Fentanyl<br>* Fentanyl 1 µg/kg diluted to 2 ml with 0.9% normal saline was administration. If adverse events were occurred, the patient will receive rescue drugs.<br>Drug: 0.9% normal saline<br>* 0.9% normal saline was use to dilute the study drugs<br>Device: Skull pins<br>* Skull pins were use to stabilized the patent' s head during surgery<br>* Other names: Mayfield;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure | Blood pressure was recorded by the blinded anesthesiologist | Baseline in time frame before pin insertion (T1-T4) , time during pin insertion (T5), repeated measurement time every 1 minute until 5 minutes after pin applications (T6-T10). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean arterial pressure | Mean arterial pressure was recorded by the blinded anesthesiologist | Baseline in time frame before pin insertion (T1-T4), time during pin insertion (T5), repeated measurement time every 1 minute until 5 minutes after pin applications (T6-T10). | 
| Change in heart rate | Heart rate was recorded by the blinded anesthesiologist | Baseline in time frame before pin insertion (T1-T4), time during pin insertion (T5), repeated measurement time every 1 minute until 5 minutes after pin applications (T6-T10). | 
| adverse events | Adverse events were recorded by the blinded anesthesiologist. Rescue drugs were give when adverse events were occurred. Rescue drug include propofol (for hypertension), ephedrine(for hypotension), esmolol (for tachycardia), atropine (for bradycardia) | Baseline in time frame before pin insertion (T1-T4), time during pin insertion (T5), repeated measurement time every 1 minute until 5 minutes after pin applications (T6-T10). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodynamic response, Skull pins application, Dexmedetomidine, Fentanyl