Spinal DiseasesPhase 4NCT02535273

The Effect of Dexmedetomidine Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia

A Phase 4 study testing Dexmedetomidine, Lidocaine and Low-dose Dexmedetomidine in people with Spinal Diseases and Local Anesthesia, run by Tang-Du Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Evaluate safety and efficacy of dexmedetomidine in minimally invasive spine surgery under local anesthesia sedation.Explore the appropriate concentration of dexmedetomidine, whether or not can reduce the amount of local anesthetics. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Diseases, Local Anesthesia
What is being tested?: Dexmedetomidine, Lidocaine and Low-dose Dexmedetomidine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 212 participants
Where: No sites listed yet
Study dates: Sep 2015to Sep 2016
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Sign the informed consent；
American Society of Anesthesiologists (ASA)classification:class I~II;Elective minimally invasive spine surgery；
Age ≥18 years old, weighing 45 ~ 80 Kg, height 151 ~ 185 cm;
hypertension within Ⅱ grade, or controlled with drugs within Ⅱ level；
Diabetes fasting in 8.3mol/L or less

Who cannot join

DEX allergy;
Change anesthesia preoperative or intraoperative ;
metabolic disorders, anemia has not been corrected;
recent patients receiving sedatives and antidepressants;
degenerative diseases of the central nervous elderly persons;
serious central nervous system diseases (acute stroke, uncontrolled epilepsy, severe dementia);

Show all 11Show fewer

hypovolemia; 8) unstable angina or acute myocardial infarction;
left ventricular ejection fraction less than 30%, heart rate lower than 45bpm;
II-III degree heart block;
acute hepatitis or severe liver disease (liver function C level);
patients with renal insufficiency randomly assigned to receive treatment, but If patients need dialysis test is excluded or interruption ;

About this study

Official title: The Effect of Dexmedetomidine Subsidiary Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia：A Randomized, Double Blind Controlled Trial

Conditions: Spinal Diseases, Local Anesthesia
Being tested: Dexmedetomidine, Lidocaine, Low-dose Dexmedetomidine, Moderate-dose Dexmedetomidine, High-dose Dexmedetomidine
Keywords: dexmedetomidine, prone position, spine surgery, Minimally invasive, local anesthesia
Medical subject headings: Spinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
Also called Yisi
load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
LidocaineDrug
Also called Lidocaine Hydrochloride Injection
local anesthesia：0.67% lidocaine local anesthesia layer by layer to the periosteum at the puncture site，Establish puncture channel, injection 5ml 0.67% lidocaine into the vertebral body through the catheter, and observe 5-10min before operation
Low-dose DexmedetomidineDrug
Also called Yisi
maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery
Moderate-dose DexmedetomidineDrug
Also called Yisi
maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery
High-dose DexmedetomidineDrug
Also called Yisi
maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery
normal salineDrug
Also called Sodium Chloride Physiological Solution
Intravenous injection normal saline equal quantity，completed within 10 minutes. Intravenous infusion of normal saline 0.125 μg/kg/min until the end of surgery

Study groups in NCT02535273
Study group	Role	What they receive
Low-dose Dexmedetomidine	Experimental	load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes. Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery Receives: Drug: Dexmedetomidine; Drug: Lidocaine; Drug: Low-dose Dexmedetomidine
Moderate-dose Dexmedetomidine	Experimental	load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes. Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery Receives: Drug: Dexmedetomidine; Drug: Lidocaine; Drug: Moderate-dose Dexmedetomidine
High-dose Dexmedetomidine	Experimental	load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes. Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery Receives: Drug: Dexmedetomidine; Drug: Lidocaine; Drug: High-dose Dexmedetomidine
normal saline Control group	Placebo comparator	Intravenous injection normal saline equal quantity，completed within 10 minutes. Local anesthesia: lidocaine Intravenous infusion of normal saline 0.125 μg/kg/min until the end of surgery Receives: Drug: Lidocaine; Drug: normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Ramsay sedation score
Evaluation time point：1min before dexmedetomidine infusion；1min before local anesthesia；lidocaine infiltrate layer by layer to the periosteum，assessed up to 2min；Intraoperative most painful moments，assessed up to 5min；1min before returning to the ward；2h after surgery.Intraoperative most painful moments：nucleus pulpous probe or Balloon Dilatation.
Measured: From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours
visual analogue scale
Evaluation time point：1min before dexmedetomidine infusion；1min before local anesthesia；lidocaine infiltrate layer by layer to the periosteum，assessed up to 2min；Intraoperative most painful moments，assessed up to 5min；1min before returning to the ward；2h after surgery.Intraoperative most painful moments：nucleus pulpous probe or Balloon Dilatation.
Measured: From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours

Secondary outcomes (2)

The total amount of lidocaine
Measured: 2h after surgery；
The patient and the surgeon satisfaction
four grades：Very satisfied; General satisfied; Not satisfied; Very dissatisfied
Measured: 2h after surgery；

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Sep 2016

First posted28 Aug 2015 (estimated)
Study startSep 2015
Primary completionAug 2016 (estimated)
Study completionSep 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Spinal DiseasesStudies of the same condition, open and under way.
More trials run by Tang-Du HospitalThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 212 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02535273
Sponsor's protocol ID: Tangdu-dex-loc
Status last verified: Aug 2015
First submitted: 20 Aug 2015
Last updated: 28 Aug 2015
Results posted: No
Data monitoring committee: No

Publications

Nakamura Y, Yabuki S, Kikuchi S, Konno S. Minimally invasive surgery for osteoid osteoma of the cervical spine using microendoscopic discectomy system. Asian Spine J. 2013 Jun;7(2):143-7. doi: 10.4184/asj.2013.7.2.143. Epub 2013 May 22.
PubMed 23741555
Smith N, Masters J, Jensen C, Khan A, Sprowson A. Systematic review of microendoscopic discectomy for lumbar disc herniation. Eur Spine J. 2013 Nov;22(11):2458-65. doi: 10.1007/s00586-013-2848-8. Epub 2013 Jun 23.
PubMed 23793558
Yoshimoto M, Takebayashi T, Ida K, Tanimoto K, Yamashita T. Microendoscopic discectomy in athletes. J Orthop Sci. 2013 Nov;18(6):902-8. doi: 10.1007/s00776-013-0442-x. Epub 2013 Jul 20.
PubMed 23873279
Gandhi SD, Anderson DG. Minimally invasive surgery for the lumbar spine. J Neurosurg Sci. 2012 Mar;56(1):27-34.
PubMed 22415380
Arts MP. Reply to the letter to the editor of R. Q. Knight concerning "does minimally invasive lumbar disc surgery result in less muscle injury than conventional surgery? A randomized controlled trial" by M. Arts, R. Brand, et al. (2011) Eur Spine J 20(1):51-57. doi:10.1007/s00586-012-2491-9. Eur Spine J. 2013 Apr;22(4):899. doi: 10.1007/s00586-012-2643-y. Epub 2013 Jan 9. No abstract available.
PubMed 23299723

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Dexmedetomidine Subsidiary Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia：A Randomized, Double Blind Controlled Trial
ClinicalTrials.gov ID: NCT02535273
Acronym / sponsor ID: Tangdu-dex-loc
Conditions: Spinal Diseases, Local Anesthesia
Keywords: dexmedetomidine, prone position, spine surgery, Minimally invasive, local anesthesia
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 212 participants (estimated)
Lead sponsor: Tang-Du HospitalUniversity, hospital or other
Study start: Sep 2015
Primary completion: Aug 2016 (estimated)
Study completion: Sep 2016 (estimated)
First posted: 28 Aug 2015 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Low-dose Dexmedetomidine	Experimental	Drug: Dexmedetomidine, Drug: Lidocaine, Drug: Low-dose Dexmedetomidineload dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes. Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery
Moderate-dose Dexmedetomidine	Experimental	Drug: Dexmedetomidine, Drug: Lidocaine, Drug: Moderate-dose Dexmedetomidineload dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes. Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery
High-dose Dexmedetomidine	Experimental	Drug: Dexmedetomidine, Drug: Lidocaine, Drug: High-dose Dexmedetomidineload dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes. Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery
normal saline Control group	Placebo comparator	Drug: Lidocaine, Drug: normal salineIntravenous injection normal saline equal quantity，completed within 10 minutes. Local anesthesia: lidocaine Intravenous infusion of normal saline 0.125 μg/kg/min until the end of surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Sign the informed consent；
American Society of Anesthesiologists (ASA)classification:class I~II;Elective minimally invasive spine surgery；
Age ≥18 years old, weighing 45 ~ 80 Kg, height 151 ~ 185 cm;
hypertension within Ⅱ grade, or controlled with drugs within Ⅱ level；
Diabetes fasting in 8.3mol/L or less

Key exclusion criteria (11 listed)

DEX allergy;
Change anesthesia preoperative or intraoperative ;
metabolic disorders, anemia has not been corrected;
recent patients receiving sedatives and antidepressants;
degenerative diseases of the central nervous elderly persons;

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
DexmedetomidineAlso: Yisiload dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.	Drug	High-dose Dexmedetomidine, Low-dose Dexmedetomidine, Moderate-dose Dexmedetomidine
LidocaineAlso: Lidocaine Hydrochloride Injectionlocal anesthesia：0.67% lidocaine local anesthesia layer by layer to the periosteum at the puncture site，Establish puncture channel, injection 5ml 0.67% lidocaine into the vertebral body through the catheter, and observe 5-10min before operation	Drug	High-dose Dexmedetomidine, Low-dose Dexmedetomidine, Moderate-dose Dexmedetomidine, normal saline Control group
Low-dose DexmedetomidineAlso: Yisimaintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery	Drug	Low-dose Dexmedetomidine
Moderate-dose DexmedetomidineAlso: Yisimaintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery	Drug	Moderate-dose Dexmedetomidine
High-dose DexmedetomidineAlso: Yisimaintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery	Drug	High-dose Dexmedetomidine
normal salineAlso: Sodium Chloride Physiological SolutionIntravenous injection normal saline equal quantity，completed within 10 minutes. Intravenous infusion of normal saline 0.125 μg/kg/min until the end of surgery	Drug	normal saline Control group

Primary outcome

Ramsay sedation score
Time frame: From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours
Evaluation time point：1min before dexmedetomidine infusion；1min before local anesthesia；lidocaine infiltrate layer by layer to the periosteum，assessed up to 2min；Intraoperative most painful moments，assessed up to 5min；1min before returning to the ward；2h after surgery.Intraoperative most painful moments：nucleus pulpous probe or Balloon Dilatation.
visual analogue scale
Time frame: From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours
Evaluation time point：1min before dexmedetomidine infusion；1min before local anesthesia；lidocaine infiltrate layer by layer to the periosteum，assessed up to 2min；Intraoperative most painful moments，assessed up to 5min；1min before returning to the ward；2h after surgery.Intraoperative most painful moments：nucleus pulpous probe or Balloon Dilatation.

2 secondary outcomes

The total amount of lidocaine
Time frame: 2h after surgery；
The patient and the surgeon satisfaction
Time frame: 2h after surgery；

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2015.
Background: PubMed 23741555Nakamura Y, Yabuki S, Kikuchi S, Konno S. Minimally invasive surgery for osteoid osteoma of the cervical spine using microendoscopic discectomy system. Asian Spine J. 2013 Jun;7(2):143-7. doi: 10.4184/asj.2013.7.2.143. Epub 2013 May 22.
Background: PubMed 23793558Smith N, Masters J, Jensen C, Khan A, Sprowson A. Systematic review of microendoscopic discectomy for lumbar disc herniation. Eur Spine J. 2013 Nov;22(11):2458-65. doi: 10.1007/s00586-013-2848-8. Epub 2013 Jun 23.
Background: PubMed 23873279Yoshimoto M, Takebayashi T, Ida K, Tanimoto K, Yamashita T. Microendoscopic discectomy in athletes. J Orthop Sci. 2013 Nov;18(6):902-8. doi: 10.1007/s00776-013-0442-x. Epub 2013 Jul 20.
Background: PubMed 22415380Gandhi SD, Anderson DG. Minimally invasive surgery for the lumbar spine. J Neurosurg Sci. 2012 Mar;56(1):27-34.
Background: PubMed 23299723Arts MP. Reply to the letter to the editor of R. Q. Knight concerning "does minimally invasive lumbar disc surgery result in less muscle injury than conventional surgery? A randomized controlled trial" by M. Arts, R. Brand, et al. (2011) Eur Spine J 20(1):51-57. doi:10.1007/s00586-012-2491-9. Eur Spine J. 2013 Apr;22(4):899. doi: 10.1007/s00586-012-2643-y. Epub 2013 Jan 9. No abstract available.

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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.

Sun Li principal investigator

Air Force Military Medical University, China

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine, Lidocaine and Low-dose Dexmedetomidine in people with Spinal Diseases and Local Anesthesia, run by Tang-Du Hospital.

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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Ramsay sedation score (time frame: From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02535273, which also lists 5 linked publications.

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 Aug 2015.