Dexmedetomidine in Spinal Anesthesia

Anxiety Clinical Trial

Official title:

Hemodynamic Effect of Dexmedetomidine on Heavy Bupivacaine Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155010
• Other study ID #: 2014-003
• Status: Completed
• Phase: N/A
• First received: May 22, 2014
• Last updated: August 9, 2015
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Anxiety
• Blood Pressure

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
• Dexmedetomidine with heavy bupivacaine
Dexmedetomidine infusion after IT of heavy bupivacaine

Locations

Country	Name	City	State
Korea, Republic of	Inje University, Haeundae paik hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic effects	We compare heart rate, blood pressure, oxygen saturation, exhaled carbon dioxide concentration and bispectral index between two groups.	During operation and at post-anesthetic care unit (average of 4-5 hours)	No
Secondary	Patient's comfortability and anxiety	We measure korea version of state-trait anxiety inventory, comfortability (1=not comfortable,2=comfortable, 3=very comfortable) and visual analogue scale for patient's comfortability and anxiety.	during operation and at post-anesthetic care unit (average 4-5 hours)	No