The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery

Spinal Stenosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902380
• Other study ID #: 4-2016-0644
• Status: Completed
• Phase: N/A
• First received: September 6, 2016
• Last updated: February 27, 2018
• Start date: September 27, 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: February 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Surgical stress induces stress hormone release and sympathetic hyperactivation. Dexmedetomidine has sympatholytic effect and attenuates stress responses. This study investigate the effect of dexmedetomidine on stress responses and autonomic nervous system balance in patients undergoing major spine surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• patient between 20 and 70 of age with ASA physical status ?-?

• patient scheduled for major spine surgery

Exclusion Criteria:

• ASA physical status ?

• congestive heart failure

• severe hepatorenal disease

• insulin dependent DM(diabetes mellitus)

• cancer or metastasis

• pregnancy

• problem with communication

Related Conditions & MeSH terms

• Spinal Stenosis

Intervention

Drug:
• dexmedetomidine group
dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery
• control group
0.9% saline infusion

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress hormone level	The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.	immediately after anesthetic induction
Primary	Stress hormone level	The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.	1 hour after start of surgery
Primary	Stress hormone level	The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.	2-hour after start of surgery
Primary	Stress hormone level	The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.	1 second after the end of surgery
Primary	Stress hormone level	The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.	1 hour after the end of surgery