Dexmedetomidine in Spinal Anesthesia

NCT ID: NCT02155010

Last Updated: 2016-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-07-31

Brief Summary

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Patients were randomized into two groups, A group and B group. A group and B group patients are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine, respectively.

The investigators will compare of hemodynamics and patient's comfortability between two groups.

Detailed Description

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A and B group patients will intravenous inject dexmedetomidine 1mcg/kg for 10 minute loading infusion and 0.2mcg/kg/hr for continuous infusion. A group receive intravenous dexmedetomidine after procedure, and B group receive intravenous dexmedetomidine before procedure. Both group patients will hydrate 6 ml/kg crystalloid solution and will evaluated patient's anxiety and comfortability perioperative period. Vital signs will record 5 minutes interval at operating room and post-anesthetic care units.

Conditions

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Blood Pressure Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexmedetomidine

IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine

Dexmedetomidine with heavy bupivacaine

IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine with heavy bupivacaine

Intervention Type DRUG

Dexmedetomidine infusion after IT of heavy bupivacaine

Interventions

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Dexmedetomidine

Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine

Intervention Type DRUG

Dexmedetomidine with heavy bupivacaine

Dexmedetomidine infusion after IT of heavy bupivacaine

Intervention Type DRUG

Other Intervention Names

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Precedex Precedex Marcaine

Eligibility Criteria

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Inclusion Criteria

* 20 - 60 aged patients
* orthopedic operation undergoing spinal anesthesia

Exclusion Criteria

* more than American society of anesthesiologists classification 3
* hypertension
* diabetes mellitus
* heart disease (bradycardia, atrioventricular block)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Ki Hwa Lee

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ki Hwa Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Inje University Haeundae Paik Hospital

Locations

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Inje University, Haeundae paik hospital

Busan, , South Korea

Site Status

Countries

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South Korea

References

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Kang E, Lee KH, Jeon SY, Lee KW, Ko MJ, Kim H, Kim YH, Jung JW. The timing of administration of intravenous dexmedetomidine during lower limb surgery: a randomized controlled trial. BMC Anesthesiol. 2016 Nov 21;16(1):116. doi: 10.1186/s12871-016-0282-2.

Reference Type DERIVED
PMID: 27871236 (View on PubMed)

Other Identifiers

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2014-003

Identifier Type: -

Identifier Source: org_study_id

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