Dexmedetomidine in Spinal Anesthesia

NCT02155010 | Completed Results

• 1 other identifier: 2014-003
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Anxiety

Keywords

Dexmedetomidine; Spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypotension

  We compare incidence rate of hypotension during infusion of dexmedetomidine

  up to 3 hours

Secondary Outcomes (1)

• Patient's Anxiety

  up to 3 days

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine

Drug: Dexmedetomidine

Dexmedetomidine with heavy bupivacaine

ACTIVE COMPARATOR

IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine

Drug: Dexmedetomidine with heavy bupivacaine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine

Also known as: Precedex

Dexmedetomidine

Dexmedetomidine with heavy bupivacaine DRUG

Dexmedetomidine infusion after IT of heavy bupivacaine

Also known as: Precedex, Marcaine

Dexmedetomidine with heavy bupivacaine

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged patients
• orthopedic operation undergoing spinal anesthesia

You may not qualify if:

• more than American society of anesthesiologists classification 3
• hypertension
• diabetes mellitus
• heart disease (bradycardia, atrioventricular block)

Sponsors & Collaborators

• Inje University: lead

Study Sites (1)

Inje University, Haeundae paik hospital

Busan, 612-896, South Korea

Location

Related Publications (1)

• 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.

  PMID: 27871236 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Dexmedetomidine; Bupivacaine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

We did not assess the differences among the groups regarding postoperative analgesic consumption and the duration of sensory or motor bloakade produced by spinal anesthesia with dexmedetomidine infusion.

Results Point of Contact

• Title: Ki Hwa Lee
• Organization: Haeundae paik hospital, Inje University

tedy3333@naver.com

82-51-797-0421

Study Officials

• Ki Hwa Lee, MD

  Inje University Haeundae Paik Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 4, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 26, 2016
• Results First Posted: September 26, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)