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

Phase 4

Completed

• Conditions: Hemodynamic Response; Skull Pins Application
• Interventions: Drug: Fentanyl; Drug: Dexmedetomidine; Drug: 0.9% normal saline; Device: Skull pins

• Registration Number: NCT03077503
• Lead Sponsor: Khon Kaen University

Brief 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).

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Study First Submitted: 2017-03-04
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine (Group A)	Skull pins	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.
Fentanyl (group B)	Fentanyl	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
Fentanyl (group B)	0.9% normal saline	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
Dexmedetomidine (Group A)	Dexmedetomidine	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.
Dexmedetomidine (Group A)	0.9% normal saline	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.
Fentanyl (group B)	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

Primary Outcome Measures

Name	Time	Method
Change in blood pressure	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).	Blood pressure was recorded by the blinded anesthesiologist

Secondary Outcome Measures

Name	Time	Method
adverse events	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 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)
Change in mean arterial pressure	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).	Mean arterial pressure was recorded by the blinded anesthesiologist
Change in heart rate	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).	Heart rate was recorded by the blinded anesthesiologist

Trial Locations

Locations (1)

Khon Kaen University; 🇹🇭 Khon Kaen, Thailand