Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution

Craniotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606969
• Other study ID #: 4-2012-0062
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA I-II

• 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

Related Conditions & MeSH terms

• Craniotomy

Intervention

Drug:
• scalp infiltration solution
Dex group: Dexmedetomidine 2mcg/ml-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)
• scalp infiltration solution
1:100000 epinephrine-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial pressure	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)	before and after scalp injection