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

NCT03077503 | Completed Phase 4

• 1 other identifier: HE581303
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemodynamic Response; Skull Pins Application

Keywords

Hemodynamic response; Skull pins application; Dexmedetomidine; Fentanyl

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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).

• 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).

• 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).

Study Arms (2)

Dexmedetomidine (Group A)

EXPERIMENTAL

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; Drug: 0.9% normal saline; Device: Skull pins

Fentanyl (group B)

ACTIVE COMPARATOR

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; Drug: 0.9% normal saline; Device: Skull pins

Interventions

Dexmedetomidine 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.

Also known as: precedex

Dexmedetomidine (Group A)

Fentanyl 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.

Fentanyl (group B)

0.9% normal saline DRUG

0.9% normal saline was use to dilute the study drugs

Dexmedetomidine (Group A); Fentanyl (group B)

Skull pins DEVICE

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

Also known as: Mayfield

Dexmedetomidine (Group A); Fentanyl (group B)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients who scheduled for elective craniotomy under general anesthesia
• patient with American Society of Anesthesiologists physical status classification of I and II

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• 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.

  PMID: 26903671 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pornthep Kasemsiri, MD

  Khon Kaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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 Record Dates

• First Submitted: March 4, 2017
• First Posted: March 13, 2017
• Study Start: September 1, 2015
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

TH (1)