Dexmedetomidine in Spinal Anesthesia

Not Applicable

Completed

• Conditions: Anxiety; Blood Pressure
• Interventions: Drug: Dexmedetomidine with heavy bupivacaine; Drug: Dexmedetomidine

• Registration Number: NCT02155010
• Lead Sponsor: Inje University

Brief Summary

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

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2015-12-10
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-03
• Last Update Submitted: 2016-08-03
• Results First Posted: 2016-09-26
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine with heavy bupivacaine	Dexmedetomidine with heavy bupivacaine	IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine
Dexmedetomidine	Dexmedetomidine	IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine

Primary Outcome Measures

Name	Time	Method
Incidence of Hypotension	up to 3 hours	We compare incidence rate of hypotension during infusion of dexmedetomidine

Secondary Outcome Measures

Name	Time	Method
Patient's Anxiety	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.

Trial Locations

Locations (1)

Inje University, Haeundae paik hospital; 🇰🇷 Busan, Korea, Republic of