Comparison of Dexmedetomidine and Fentanyl to Prevent Hemodynamic Response to Skull Pins Application
Condition: Hemodynamic Response; Skull Pins Application
Study type: Interventional
Phase: Phase 4

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

Detailed 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).
    

Intervention name(s): Dexmedetomidine; Fentanyl; 0.9% normal saline; Skull pins
Intervention type(s): Drug; Drug; Drug; Device
Intervention description(s): 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.; 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.; 0.9% normal saline was use to dilute the study drugs; Skull pins were use to stabilized the patent' s head during surgery
Other intervention name(s): precedex; Mayfield
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemodynamic response; Skull pins application; Dexmedetomidine; Fentanyl