NCT01606969

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

May 20, 2012

Last Update Submit

May 16, 2018

Conditions

Craniotomy

Keywords

Dexmedetomidineepinephrinelidocainescalp infiltrationcraniotomy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Dex group

EXPERIMENTAL

dexmedetomidine-lidocaine solution,

Drug: scalp infiltration solution

Control group

ACTIVE COMPARATOR

epinephrine-lidocaine solution

Drug: scalp infiltration solution

Interventions

scalp infiltration solutionDRUG

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

Dex group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II
  • Aged between 20 and 70 year
  • general anesthesia for craniotomy

You may not qualify if:

  • Congestive heart failure, coronary artery occlusive disease
  • Bradycardia \< 50 BPM, 2nd degree \< AV block
  • Poorly controlled hypertension
  • ß blocker medication
  • Coagulopathy
  • Pregnancy, nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2012

First Posted

May 28, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations

KR(1)