NCT02902380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

September 27, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

September 6, 2016

Last Update Submit

February 27, 2018

Conditions

Spinal Stenosis

Outcome Measures

Primary Outcomes (5)

  • Stress hormone level

    The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.

    immediately after anesthetic induction

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery

Drug: dexmedetomidine group

Control Group

PLACEBO COMPARATOR

0.9% saline infusion

Drug: control group

Interventions

dexmedetomidine groupDRUG

dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery

Dexmedetomidine Group
control groupDRUG

0.9% saline infusion

Control Group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
  • patient scheduled for major spine surgery

You may not qualify if:

  • ASA physical status Ⅳ
  • congestive heart failure
  • severe hepatorenal disease
  • insulin dependent DM(diabetes mellitus)
  • cancer or metastasis
  • pregnancy
  • problem with communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 15, 2016

Study Start

September 27, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

February 28, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)