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

Hemodynamic Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077503
• Other study ID #: HE581303
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2015
• Est. completion date: September 30, 2016

Study information

• Verified date: August 2020
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodynamic Response
• Skull Pins Application

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
Thailand	Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).