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

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ClinicalTrials.gov Identifier: NCT03077503
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Pornthep Kasemsiri, Khon Kaen University

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

Condition or disease Intervention/treatment Phase
Hemodynamic Response Skull Pins Application Drug: Dexmedetomidine Drug: Fentanyl Drug: 0.9% normal saline Device: Skull pins Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Comparison of Dexmedetomidine and Fentanyl to Prevent Hemodynamic Response to Skull Pins Application in Neurosurgery:Double Blind Randomized Controlled Trial
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Name: precedex

Drug: 0.9% normal saline
0.9% normal saline was use to dilute the study drugs

Device: Skull pins
Skull pins were use to stabilized the patent' s head during surgery
Other Name: Mayfield

Active Comparator: 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
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.

Drug: 0.9% normal saline
0.9% normal saline was use to dilute the study drugs

Device: Skull pins
Skull pins were use to stabilized the patent' s head during surgery
Other Name: Mayfield




Primary Outcome Measures :
  1. Change in blood pressure [ 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). ]
    Blood pressure was recorded by the blinded anesthesiologist


Secondary Outcome Measures :
  1. Change in mean arterial pressure [ 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). ]
    Mean arterial pressure was recorded by the blinded anesthesiologist

  2. Change in heart rate [ 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). ]
    Heart rate was recorded by the blinded anesthesiologist

  3. adverse events [ 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 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)



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077503


Locations
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Thailand
Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
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Principal Investigator: Pornthep Kasemsiri, MD Khon Kaen University

Publications of Results:
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Responsible Party: Pornthep Kasemsiri, Clinical Assistant Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT03077503     History of Changes
Other Study ID Numbers: HE581303
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pornthep Kasemsiri, Khon Kaen University:
Hemodynamic response
Skull pins application
Dexmedetomidine
Fentanyl
Additional relevant MeSH terms:
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Fentanyl
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics