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

Khon Kaen University

Status and phase: Completed; Phase 4

Conditions: Skull Pins Application; Hemodynamic Response

Treatments: Drug: Fentanyl; Drug: 0.9% normal saline; Drug: Dexmedetomidine; Device: Skull pins

Study type: Interventional

Funder types: Other

Identifiers

NCT03077503

HE581303

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Dexmedetomidine (Group A)

Experimental group

Description:

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.

Treatment:

Device: Skull pins

Drug: Dexmedetomidine

Drug: 0.9% normal saline

Fentanyl (group B)

Active Comparator group

Description:

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

Treatment:

Device: Skull pins

Drug: Fentanyl

Drug: 0.9% normal saline