Dexmedetomidine in Spinal Anesthesia

August 3, 2016 updated by: Ki Hwa Lee, Inje University

Hemodynamic Effect of Dexmedetomidine on Heavy Bupivacaine Spinal Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 612-896
        • Inje University, Haeundae paik hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine
IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
Drug: Dexmedetomidine
Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
Other Names:
  • Precedex
Active Comparator: Dexmedetomidine with heavy bupivacaine
IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine
Drug: Dexmedetomidine with heavy bupivacaine
Dexmedetomidine infusion after IT of heavy bupivacaine
Other Names:
  • Marcaine
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Hypotension
Time Frame: up to 3 hours
We compare incidence rate of hypotension during infusion of dexmedetomidine
up to 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's Anxiety
Time Frame: up to 3 days
We compared patient's anxiety using spielberger's state-trait anxiety inventory before and after surgery. This consists of two self-evaluation scales designed to assess state-anxiety and trait-anxiety. Each scale contains 20 items, each of which is rated from 1 to 4. Clinically significant levels of state or trait-anxiety were defined as scores >50 on the state- or trait-anxiety scale. State or trait-anxiety inventory's minimal score is 20 and maximal score is 80. We analyzed State Anxiety Inventory scale before and after surgery.
up to 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Principal Investigator: Ki Hwa Lee, MD, Inje University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 26, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available within 3 years of study completion.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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