Collapse of Thoracic VertebraPhase 4NCT01850017
Study of Dexmedetomidine in Spine Surgery
A Phase 4 study testing Dexmedetomidine in people with Collapse of Thoracic Vertebra and Collapse of Lumbar Vertebrae, run by University of Virginia at 1 site in United States.
Trial summary
The investigators will conduct a prospective randomized double blind study comparing methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in two randomized groups. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Collapse of Thoracic Vertebra, Collapse of Lumbar Vertebrae
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to May 2015
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80 years of age
- Elective multi-level thoracic and/or lumbar spine surgery requiring SSEP, EMG or MEP monitoring
Who cannot join
- Emergency spine surgery
- Age < 18 years
- Pregnant patients
- Advanced heart block: Mobitz type II block or atrio-ventricular dissociation in a previous EKG.
- Any individual with stage 4 or greater chronic kidney disease (eGFR< 30 ml/min) and/or requiring dialysis or liver failure defined as a history of cirrhosis or fulminant hepatic failure
- Any individuals on preoperative methadone therapy
Show all 9Show fewer
- Preoperative dexmedetomidine use
- Preoperative systolic hypertension defined by a systolic blood pressure greater than 150 mmHg in the surgical admission suite
- Enrolled in another study within 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Prospective Randomized Double Blind Study of Intraoperative Dexmedetomidine and Postoperative Pain Control in Patients Undergoing Multi-level Thoraco-lumbar Spine Surgery
The investigators will conduct a prospective randomized double blind study comparing methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in two randomized groups. The investigators plan to document the intraoperative opioid requirements, time to first dose of opioids postoperatively and total opioid consumption in the first 24, 48 and 72 hours. The incidence of intra and postoperative complications will be assessed.
Read the detailed description
Patients presenting for thoracic and/or lumbar spine surgery with neuromonitoring (MEP/SSEP/EMG)will be recruited. Standard anesthesia monitoring will be performed. Randomized to a placebo or dexmedetomidine arm. Both groups will receive methadone 0.2 mg/kg ideal weight after induction of anesthesia.
The placebo/dexmedetomidine will be loaded at 1 mcg/kg over 20 minutes and then a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure.
Intraoperative analgesia will be provided with fentanyl and dilaudid per the anesthesia team.
Upon closure the study drug will be terminated. Patients will be followed up for 72 hours after surgery. Total opiate consumption and visual analogue scale ratings will be documented.
Intra and postoperative inotrope/pressor requirements will be recorded.
- Being tested
- Dexmedetomidine
- Keywords
- Opiate consumption, Visual Analogue Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
In the intervention arm dexmedetomidine at a dose of 1 mcg/kg over 20 mins followed by an infusion of 0.5 mcg/kg/h for the duration of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Methadone and dexmedetomidine | Experimental | Standard American Society of Anesthesiology monitors. Midazolam 1-2 mg for pre-operative sedation. Lidocaine 0.5-1 mg/kg with induction. Propofol 1-2 mg/kg with induction. Fentanyl 0.5-1 mcg/kg with induction. Rocuronium 0.5 -1 mg/kg with induction. Total intravenous anesthesia with propofol for maintainence of anesthesia. Titrated to maintain BIS (bispectral index) between 30-60.
Methadone 0.2 mg/kg ideal body weight and dexmedetomidine 1 mcg/kg load over 20 minutes followed by a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure. Receives: Drug: Dexmedetomidine |
| Methadone and placebo | No intervention | Standard American Society of Anesthesiology monitors. Midazolam 1-2 mg for pre-operative sedation. Lidocaine 0.5-1 mg/kg with induction. Propofol 1-2 mg/kg with induction. Fentanyl 0.5-1 mcg/kg with induction. Rocuronium 0.5 -1 mg/kg with induction. Total intravenous anesthesia with propofol for maintainence of anesthesia. Titrated to maintain BIS (bispectral index) between 30-60. Methadone 0.2 mg/kg ideal body weight and placebo (normal saline) 1 mcg/kg load over 20 minutes followed by a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate consumption
We will measure total opiate consumption 72 hours post surgery
Measured: 72 hours post surgery
Secondary outcomes (1)
Pain Scores on the Visual Analog Scale
We will measure pain scores on the Visual analogue scale after surgery
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startAug 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Collapse of Thoracic VertebraStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhiken I. Naik, MD, University of Virginia
- Investigators
- Bhiken Naik, MBBCh, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850017
- Sponsor's protocol ID
- 16150
- Status last verified
- May 2017
- First submitted
- 30 Apr 2013
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
PubMed 20418538Korkmaz Dilmen O, Tunali Y, Cakmakkaya OS, Yentur E, Tutuncu AC, Tureci E, Bahar M. Efficacy of intravenous paracetamol, metamizol and lornoxicam on postoperative pain and morphine consumption after lumbar disc surgery. Eur J Anaesthesiol. 2010 May;27(5):428-32. doi: 10.1097/EJA.0b013e32833731a4.
PubMed 20173643Khan ZH, Rahimi M, Makarem J, Khan RH. Optimal dose of pre-incision/post-incision gabapentin for pain relief following lumbar laminectomy: a randomized study. Acta Anaesthesiol Scand. 2011 Mar;55(3):306-12. doi: 10.1111/j.1399-6576.2010.02377.x.
PubMed 21288211Loftus RW, Yeager MP, Clark JA, Brown JR, Abdu WA, Sengupta DK, Beach ML. Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery. Anesthesiology. 2010 Sep;113(3):639-46. doi: 10.1097/ALN.0b013e3181e90914.
PubMed 20693876Grewal A. Dexmedetomidine: New avenues. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):297-302. doi: 10.4103/0970-9185.83670. No abstract available.
PubMed 21897496Chan AK, Cheung CW, Chong YK. Alpha-2 agonists in acute pain management. Expert Opin Pharmacother. 2010 Dec;11(17):2849-68. doi: 10.1517/14656566.2010.511613. Epub 2010 Aug 13.
PubMed 20707597McQueen-Shadfar LA, Megalla SA, White WD, Olufolabi AJ, Jones CA, Habib AS. Impact of intraoperative dexmedetomidine on postoperative analgesia following gynecologic surgery. Curr Med Res Opin. 2011 Nov;27(11):2091-7. doi: 10.1185/03007995.2011.618491. Epub 2011 Sep 14.
PubMed 21916531Turgut N, Turkmen A, Gokkaya S, Altan A, Hatiboglu MA. Dexmedetomidine-based versus fentanyl-based total intravenous anesthesia for lumbar laminectomy. Minerva Anestesiol. 2008 Sep;74(9):469-74.
PubMed 18762754
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double Blind Study of Intraoperative Dexmedetomidine and Postoperative Pain Control in Patients Undergoing Multi-level Thoraco-lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT01850017
- Acronym / sponsor ID
- 16150
- Keywords
- Opiate consumption, Visual Analogue Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 May 2013 (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.
The investigators will conduct a prospective randomized double blind study comparing methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in two randomized groups. The investigators plan to document the intraoperative opioid requirements, time to first dose of opioids postoperatively and total opioid consumption in the first 24, 48 and 72 hours. The incidence of intra and postoperative complications will be assessed.
Detailed description
Patients presenting for thoracic and/or lumbar spine surgery with neuromonitoring (MEP/SSEP/EMG)will be recruited. Standard anesthesia monitoring will be performed. Randomized to a placebo or dexmedetomidine arm. Both groups will receive methadone 0.2 mg/kg ideal weight after induction of anesthesia.
The placebo/dexmedetomidine will be loaded at 1 mcg/kg over 20 minutes and then a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure.
Intraoperative analgesia will be provided with fentanyl and dilaudid per the anesthesia team.
Upon closure the study drug will be terminated. Patients will be followed up for 72 hours after surgery. Total opiate consumption and visual analogue scale ratings will be documented.
Intra and postoperative inotrope/pressor requirements will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone and dexmedetomidine | Experimental | Drug: DexmedetomidineStandard American Society of Anesthesiology monitors. Midazolam 1-2 mg for pre-operative sedation. Lidocaine 0.5-1 mg/kg with induction. Propofol 1-2 mg/kg with induction. Fentanyl 0.5-1 mcg/kg with induction. Rocuronium 0.5 -1 mg/kg with induction. Total intravenous anesthesia with propofol for maintainence of anesthesia. Titrated to maintain BIS (bispectral index) between 30-60. Methadone 0.2 mg/kg ideal body weight and dexmedetomidine 1 mcg/kg load over 20 minutes followed by a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure. |
| Methadone and placebo | No intervention | –Standard American Society of Anesthesiology monitors. Midazolam 1-2 mg for pre-operative sedation. Lidocaine 0.5-1 mg/kg with induction. Propofol 1-2 mg/kg with induction. Fentanyl 0.5-1 mcg/kg with induction. Rocuronium 0.5 -1 mg/kg with induction. Total intravenous anesthesia with propofol for maintainence of anesthesia. Titrated to maintain BIS (bispectral index) between 30-60. Methadone 0.2 mg/kg ideal body weight and placebo (normal saline) 1 mcg/kg load over 20 minutes followed by a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80 years of age
- Elective multi-level thoracic and/or lumbar spine surgery requiring SSEP, EMG or MEP monitoring
Key exclusion criteria (9 listed)
- Emergency spine surgery
- Age < 18 years
- Pregnant patients
- Advanced heart block: Mobitz type II block or atrio-ventricular dissociation in a previous EKG.
- Any individual with stage 4 or greater chronic kidney disease (eGFR< 30 ml/min) and/or requiring dialysis or liver failure defined as a history of cirrhosis or fulminant hepatic failure
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: PrecedexIn the intervention arm dexmedetomidine at a dose of 1 mcg/kg over 20 mins followed by an infusion of 0.5 mcg/kg/h for the duration of the surgery. | Drug | Methadone and dexmedetomidine |
Primary outcome
Opiate consumption
Time frame: 72 hours post surgery
We will measure total opiate consumption 72 hours post surgery
1 secondary outcome
Pain Scores on the Visual Analog Scale
Time frame: 72 hours
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 5 May 2017.
- Background: PubMed 20418538Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
- Background: PubMed 20173643Korkmaz Dilmen O, Tunali Y, Cakmakkaya OS, Yentur E, Tutuncu AC, Tureci E, Bahar M. Efficacy of intravenous paracetamol, metamizol and lornoxicam on postoperative pain and morphine consumption after lumbar disc surgery. Eur J Anaesthesiol. 2010 May;27(5):428-32. doi: 10.1097/EJA.0b013e32833731a4.
- Background: PubMed 21288211Khan ZH, Rahimi M, Makarem J, Khan RH. Optimal dose of pre-incision/post-incision gabapentin for pain relief following lumbar laminectomy: a randomized study. Acta Anaesthesiol Scand. 2011 Mar;55(3):306-12. doi: 10.1111/j.1399-6576.2010.02377.x.
- Background: PubMed 20693876Loftus RW, Yeager MP, Clark JA, Brown JR, Abdu WA, Sengupta DK, Beach ML. Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery. Anesthesiology. 2010 Sep;113(3):639-46. doi: 10.1097/ALN.0b013e3181e90914.
- Background: PubMed 21897496Grewal A. Dexmedetomidine: New avenues. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):297-302. doi: 10.4103/0970-9185.83670. No abstract available.
- Background: PubMed 20707597Chan AK, Cheung CW, Chong YK. Alpha-2 agonists in acute pain management. Expert Opin Pharmacother. 2010 Dec;11(17):2849-68. doi: 10.1517/14656566.2010.511613. Epub 2010 Aug 13.
- Background: PubMed 21916531McQueen-Shadfar LA, Megalla SA, White WD, Olufolabi AJ, Jones CA, Habib AS. Impact of intraoperative dexmedetomidine on postoperative analgesia following gynecologic surgery. Curr Med Res Opin. 2011 Nov;27(11):2091-7. doi: 10.1185/03007995.2011.618491. Epub 2011 Sep 14.
- Background: PubMed 18762754Turgut N, Turkmen A, Gokkaya S, Altan A, Hatiboglu MA. Dexmedetomidine-based versus fentanyl-based total intravenous anesthesia for lumbar laminectomy. Minerva Anestesiol. 2008 Sep;74(9):469-74.
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.
Bhiken Naik, MBBCh principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Collapse of Thoracic Vertebra and Collapse of Lumbar Vertebrae, run by University of Virginia at 1 site in United States.
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 9 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 5 May 2017. 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 United States. 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. 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?
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?
Opiate consumption (time frame: 72 hours post surgery). 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 NCT01850017, which also lists 8 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 5 May 2017.