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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2016-09-30

Brief Summary

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

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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).

Conditions

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Hemodynamic Response Skull Pins Application

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

After written informed consents were obtained, all participant was blinded from the study drug. The study drugs (dexmedetomidine and fentanyl) were prepared by anesthetist nurse who not involved in the study. Dexmedetomidine was labeled with group A whereas fentanyl was labeled with group B. The study drug was administrated by the blinded anesthiologist. Blood pressure, mean arterial pressure, and heart rate were recorded by same blinded anesthesiologist

Study Groups

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Dexmedetomidine (Group A)

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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.

0.9% normal saline

Intervention Type DRUG

0.9% normal saline was use to dilute the study drugs

Skull pins

Intervention Type DEVICE

Skull pins were use to stabilized the patent' s head during surgery

Fentanyl (group B)

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

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

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

Intervention Type DRUG

0.9% normal saline was use to dilute the study drugs

Skull pins

Intervention Type DEVICE

Skull pins were use to stabilized the patent' s head during surgery

Interventions

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Dexmedetomidine

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.

Intervention Type DRUG

Fentanyl

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.

Intervention Type DRUG

0.9% normal saline

0.9% normal saline was use to dilute the study drugs

Intervention Type DRUG

Skull pins

Skull pins were use to stabilized the patent' s head during surgery

Intervention Type DEVICE

Other Intervention Names

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precedex Mayfield

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No