Randomized Controlled Trial to Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution for the Effect on Hemodynamic Response Due to Scalp Infiltration in Patients Undergoing Craniotomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Mean arterial pressure
Study Overview
Brief Summary
Scalp infiltration with Epinephrine- containing lidocaine solution is common method for craniotomy but it may result in transient but significant hypotension in patients undergoing neurosurgery. Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response, and dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during scalp incision in craniotomy.
The aim of this study is to compare the effect of dexmedetomidine-lidocaine solution on hemodynamic response, scalp bleeding to epinephrine-lidocaine solution.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged between 20 and 70 year
- •general anesthesia for craniotomy
Exclusion Criteria
- •Congestive heart failure, coronary artery occlusive disease
- •Bradycardia < 50 BPM, 2nd degree < AV block
- •Poorly controlled hypertension
- •ß blocker medication
- •Coagulopathy
- •Pregnancy, nursing
Arms & Interventions
Dex group
dexmedetomidine-lidocaine solution,
Intervention: scalp infiltration solution (Drug)
Control group
epinephrine-lidocaine solution
Intervention: scalp infiltration solution (Drug)
Outcomes
Primary Outcomes
Mean arterial pressure
Time Frame: before and after scalp injection
before scalp injection(T0), after scalp injection every half minute until five minutes(T0.5, T1, T1.5, T2, T2.5, T3, T3.5, T4, T4.5, T5), every minute(T6, T7, T8, T9, T10, T11, T12, T13, T14, T15)
Secondary Outcomes
No secondary outcomes reported