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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03077503
• Date of registration: 04/03/2017
• Prospective Registration: No
• Primary sponsor: Khon Kaen University
• Public title: Comparison of Dexmedetomidine and Fentanyl to Prevent Hemodynamic Response to Skull Pins Application
• Scientific title: Comparison of Dexmedetomidine and Fentanyl to Prevent Hemodynamic Response to Skull Pins Application in Neurosurgery:Double Blind Randomized Controlled Trial
• Date of first enrolment: September 1, 2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03077503
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Thailand

Contacts

• Name: Pornthep Kasemsiri, MD
• Affiliation: Khon Kaen University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hemodynamic Response

Skull Pins Application

Intervention(s)

Drug: Fentanyl

Drug: 0.9% normal saline

Device: Skull pins

Drug: Dexmedetomidine

Primary Outcome(s)

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).]

Secondary Outcome(s)

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).]

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).]

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).]

Secondary ID(s)

HE581303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors