|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT01377623 |
|
Date of registration:
|
03/01/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
|
|
Scientific title:
|
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion |
|
Date of first enrolment:
|
September 2010 |
|
Target sample size:
|
66 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT01377623 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Alex Bekker, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
NYU School of Medicine |
|
|
Name:
|
Michael Urban, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hospital for Special Surgery, New York |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Adult (> 18) male or female who will undergo surgery for spinal fusion with general
anesthesia.
2. If female, subject is non-lactating and is either:
- Not of childbearing potential
- Of childbearing potential but is not pregnant at time of baseline as determined
by pre-surgical pregnancy testing.
3. Subject is ASA physical status 1, 2, or 3.
Exclusion Criteria:
1. Cognitively impaired (by history)
2. Subject requires chronic antipsychotic history
3. Subject is anticipated to require an additional surgery within 90 days after the
intended spinal fusion
4. Subject known to be in liver failure
5. Subject has received treatment with alpha-2-agonist or antagonist within 2 weeks of
study entry
6. Subject for whom opiates, benzodiazepines, DEX are contraindicated
7. Chronic use of steroids/NSAIDs
8. Patients with serious bradycardia related arrhythmias, i.e. 2nd degree block.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Inflammation
|
|
Spinal Stenosis
|
|
Intervention(s)
|
|
Drug: Dexmedetomidine group
|
|
Drug: Placebo group
|
|
Primary Outcome(s)
|
|
Quality of Recovery Score (QoR-40)
[Time Frame: Post-operative Day 3]
|
|
Secondary Outcome(s)
|
|
Concentration of IL-1a
[Time Frame: Post-operative Day 1]
|
|
Concentration of IL-6
[Time Frame: Post-operative Day 1]
|
|
Concentration of IL-8
[Time Frame: Post-operative Day 1]
|
|
Concentration of TNF-alpha
[Time Frame: Post-operative Day 1]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|