Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01606969
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Craniotomy	Drug: scalp infiltration solution; Drug: scalp infiltration solution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dex group dexmedetomidine-lidocaine solution,	Drug: scalp infiltration solution; Dex group: Dexmedetomidine 2mcg/ml-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)
Active Comparator: Control group epinephrine-lidocaine solution	Drug: scalp infiltration solution; 1:100000 epinephrine-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)

Outcome Measures

Primary Outcome Measures

1. Mean arterial pressure [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01606969
• Other Study ID Numbers: 4-2012-0062
• First Posted: May 28, 2012
• Last Update Posted: May 21, 2018
• Last Verified: May 1, 2018

• Keywords provided by Yonsei University: Dexmedetomidine; epinephrine; lidocaine; scalp infiltration; craniotomy
• Additional relevant MeSH terms: Pharmaceutical Solutions

Study Results

No Results Posted as of May 21, 2018