Spinal StenosisNCT02902380
The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
A study testing dexmedetomidine group in people with Spinal Stenosis, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- dexmedetomidine group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Sep 2016to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
- patient scheduled for major spine surgery
Who cannot join
- ASA physical status Ⅳ
- congestive heart failure
- severe hepatorenal disease
- insulin dependent DM(diabetes mellitus)
- cancer or metastasis
- pregnancy
- problem with communication
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 03722
About this study
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.
- Conditions
- Spinal Stenosis
- Being tested
- dexmedetomidine group, control group
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine groupDrug
dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery
control groupDrug
0.9% saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery Receives: Drug: dexmedetomidine group |
| Control Group | Placebo comparator | 0.9% saline infusion Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress hormone level
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Measured: immediately after anesthetic induction
Stress hormone level
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 hour after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start27 Sep 2016
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902380
- Sponsor's protocol ID
- 4-2016-0644
- Status last verified
- Feb 2018
- First submitted
- 6 Sep 2016
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
- ClinicalTrials.gov ID
- NCT02902380
- Acronym / sponsor ID
- 4-2016-0644
- Conditions
- Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: dexmedetomidine groupdexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery |
| Control Group | Placebo comparator | Drug: control group0.9% saline infusion |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
- patient scheduled for major spine surgery
Key exclusion criteria (7 listed)
- ASA physical status Ⅳ
- congestive heart failure
- severe hepatorenal disease
- insulin dependent DM(diabetes mellitus)
- cancer or metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidine groupdexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery | Drug | Dexmedetomidine Group |
| control group0.9% saline infusion | Drug | Control Group |
Primary outcome
Stress hormone level
Time frame: immediately after anesthetic induction
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Stress hormone level
Time frame: 1 hour after start of surgery
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Stress hormone level
Time frame: 2-hour after start of surgery
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Stress hormone level
Time frame: 1 second after the end of surgery
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Stress hormone level
Time frame: 1 hour after the end of surgery
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine group in people with Spinal Stenosis, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress hormone level (time frame: immediately after anesthetic induction). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.