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

NCT ID: NCT02902380

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-27

Study Completion Date

2017-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Dexmedetomidine Group

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

Group Type EXPERIMENTAL

dexmedetomidine group

Intervention Type DRUG

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

Control Group

0.9% saline infusion

Group Type PLACEBO_COMPARATOR

control group

Intervention Type DRUG

0.9% saline infusion

Interventions

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dexmedetomidine group

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

Intervention Type DRUG

control group

0.9% saline infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2016-0644

Identifier Type: -

Identifier Source: org_study_id

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