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Completed

NCT Number: NCT02155010

Dexmedetomidine in 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.

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Key information

Conditions

Blood Pressure Anxiety Anxiety Disorders Mental Disorders

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inje University, Haeundae paik hospital

Busan, 612-896, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine

Other names: Precedex

Dexmedetomidine with heavy bupivacaine

Drug

Dexmedetomidine infusion after IT of heavy bupivacaine

Other names: Precedex, Marcaine

Primary outcomes

  1. Incidence of Hypotension

    Time frame: up to 3 hours

    We compare incidence rate of hypotension during infusion of dexmedetomidine

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

Hemodynamic Effect of Dexmedetomidine on Heavy Bupivacaine Spinal Anesthesia

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 4, 2014
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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