A Phase 4 interventional study of Dexmedetomidine and Fentanyl in Hemodynamic Response and Skull Pins Application, sponsored by Khon Kaen University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-08-20.
Sponsored by Khon Kaen University · Phase 4, Interventional, and Treatment
To compare the effect between dexmedetomidine and fentanyl for controlling the hemodynamic response to skull pins application
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).
Khon Kaen University is the lead sponsor of 160 studies on the registry; 24 are open to participants now.
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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 · Drug: 0.9% normal saline · Device: Skull pins
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 · Drug: 0.9% normal saline · Device: Skull pins
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.
Also known as: precedex
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
Also known as: Mayfield
Change in blood pressure
Blood pressure was recorded by the blinded anesthesiologist
Time frame: 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 mean arterial pressure
Mean arterial pressure was recorded by the blinded anesthesiologist
Time frame: 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
Time frame: 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)
Time frame: 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).
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Khon Kaen University