Trial · NCT01377623
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
NCT01377623, Not applicable, Terminated, NYU Langone Health; results first posted 2016-12-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion. Trials, record NCT01377623. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01377623
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
- NCT number
- NCT01377623
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 66 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Spinal Stenosis, Inflammation
- Interventions
- Dexmedetomidine group, Placebo group
- First posted
- 2011-06-21
- Last updated
- 2017-07-11
- Results first posted
- 2016-12-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Quality of Recovery Score (QoR-40) | Post-operative Day 3 | The QoR-40 is a 40 item questionnaire in which each question is answered with a score of 1-5. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). |
| Secondary | Concentration of TNF-alpha | Post-operative Day 1 | |
| Secondary | Concentration of IL-1a | Post-operative Day 1 | |
| Secondary | Concentration of IL-6 | Post-operative Day 1 | |
| Secondary | Concentration of IL-8 | Post-operative Day 1 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Quality of Recovery Score (QoR-40) | Post-operative Day 3 | units on a scale | MEAN | |
| SECONDARY | Concentration of TNF-alpha | Post-operative Day 1 | pg/ml | MEDIAN | |
| SECONDARY | Concentration of IL-1a | Post-operative Day 1 | pg/ml | MEDIAN | |
| SECONDARY | Concentration of IL-6 | Post-operative Day 1 | pg/ml | MEDIAN | |
| SECONDARY | Concentration of IL-8 | Post-operative Day 1 | pg/ml | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Quality of Recovery Score (QoR-40) | Dexmedetomidine Group (PFD) | 183.04 | Standard Deviation 2.76 | units on a scale | |
| Quality of Recovery Score (QoR-40) | Placebo Group (PFS) | 169.3 | Standard Deviation 3.87 | units on a scale | |
| Concentration of TNF-alpha | Dexmedetomidine Group (PFD) | 10.1 | Inter-Quartile Range 3.8 to 12.7 | pg/ml | |
| Concentration of TNF-alpha | Placebo Group (PFS) | 7.9 | Inter-Quartile Range 2.1 to 11.4 | pg/ml | |
| Concentration of IL-1a | Dexmedetomidine Group (PFD) | 2.52 | Inter-Quartile Range 1.4 to 3.6 | pg/ml | |
| Concentration of IL-1a | Placebo Group (PFS) | 2.58 | Inter-Quartile Range 1.4 to 2.6 | pg/ml | |
| Concentration of IL-6 | Dexmedetomidine Group (PFD) | 60.8 | Inter-Quartile Range 27.3 to 122.8 | pg/ml | |
| Concentration of IL-6 | Placebo Group (PFS) | 50.0 | Inter-Quartile Range 11.2 to 82.1 | pg/ml | |
| Concentration of IL-8 | Dexmedetomidine Group (PFD) | 20.9 | Inter-Quartile Range 12.6 to 31.2 | pg/ml | |
| Concentration of IL-8 | Placebo Group (PFS) | 16.4 | Inter-Quartile Range 6.2 to 24.6 | pg/ml |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dexmedetomidine Group (PFD) | 33 | |
| Overall Study | STARTED | Placebo Group (PFS) | 33 | |
| Overall Study | COMPLETED | Dexmedetomidine Group (PFD) | 26 | |
| Overall Study | COMPLETED | Placebo Group (PFS) | 28 | |
| Overall Study | NOT COMPLETED | Dexmedetomidine Group (PFD) | 7 | |
| Overall Study | NOT COMPLETED | Placebo Group (PFS) | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexmedetomidine Group (PFD) | ||
| Total, all-cause mortality | Placebo Group (PFS) | ||
| Total, other adverse events | Dexmedetomidine Group (PFD) | 0 | 26 |
| Total, other adverse events | Placebo Group (PFS) | 0 | 28 |
| Total, serious adverse events | Dexmedetomidine Group (PFD) | 0 | 26 |
| Total, serious adverse events | Placebo Group (PFS) | 0 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22824921 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dexmedetomidine Group (PFD) vs Placebo Group (PFS): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01377623
GET https://conductscience.org/api/trials/v1/NCT01377623/registered