Back to resultsThe Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
Primary Purpose
Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dexmedetomidine group
control group
Sponsored by
About this trial
This is an interventional other trial for Spinal Stenosis
Eligibility Criteria
Inclusion Criteria:
- patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
- patient scheduled for major spine surgery
Exclusion Criteria:
- ASA physical status Ⅳ
- congestive heart failure
- severe hepatorenal disease
- insulin dependent DM(diabetes mellitus)
- cancer or metastasis
- pregnancy
- problem with communication
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine Group
Control Group
Arm Description
dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery
0.9% saline infusion
Outcomes
Primary Outcome Measures
Stress hormone level
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Stress hormone level
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Stress hormone level
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Stress hormone level
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Stress hormone level
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02902380
Brief Title
The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 27, 2016 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine Group
Arm Type
Experimental
Arm Description
dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
0.9% saline infusion
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine group
Intervention Description
dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery
Intervention Type
Drug
Intervention Name(s)
control group
Intervention Description
0.9% saline infusion
Primary Outcome Measure Information:
Title
Stress hormone level
Description
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Time Frame
immediately after anesthetic induction
Title
Stress hormone level
Description
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Time Frame
1 hour after start of surgery
Title
Stress hormone level
Description
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Time Frame
2-hour after start of surgery
Title
Stress hormone level
Description
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Time Frame
1 second after the end of surgery
Title
Stress hormone level
Description
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Time Frame
1 hour after the end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
patient scheduled for major spine surgery
Exclusion Criteria:
ASA physical status Ⅳ
congestive heart failure
severe hepatorenal disease
insulin dependent DM(diabetes mellitus)
cancer or metastasis
pregnancy
problem with communication
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
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