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

Comparison of Dexmedetomidine and Fentanyl to Prevent Hemodynamic Response to Skull Pins Application in Neurosurgery:Double Blind Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Hemodynamic Response; Skull Pins Application
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: 0.9% normal saline; Device: Skull pins; Drug: Fentanyl

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Khon Kaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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: 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 Names: Mayfield; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Blood pressure was recorded by the blinded anesthesiologist	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean arterial pressure	Mean arterial pressure was recorded by the blinded anesthesiologist	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	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)	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).

Collaborators and Investigators

• Sponsor: Khon Kaen University

Publications and helpful links

General Publications

• Paul A, Krishna HM. Comparison between intravenous dexmedetomidine and local lignocaine infiltration to attenuate the haemodynamic response to skull pin head holder application during craniotomy. Indian J Anaesth. 2015 Dec;59(12):785-8. doi: 10.4103/0019-5049.171558.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 30, 2016
• Study Completion (Actual): September 30, 2016

Study Registration Dates

• First Submitted: March 4, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Fentanyl; Dexmedetomidine; Hemodynamic response; Skull pins application
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: HE581303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No