Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT00932386 |
| Other study ID # |
0120090056 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 4
|
| First received |
July 1, 2009 |
| Last updated |
April 23, 2015 |
| Start date |
July 2009 |
Study information
| Verified date |
April 2015 |
| Source |
Rutgers, The State University of New Jersey |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
This study is being done to determine if the drug known as dexmedetomidine improves the way
we care for patients when their surgery involves the use of a tourniquet on the leg. A
tourniquet is sometimes used for lower leg or foot surgery to decrease the blood loss for
the patient and to make it easier for the surgeon to do his work.
Description:
The study will be a prospective, randomized, double blinded, and placebo controlled clinical
trial. The subject population will consist of patients ages 18 to 80 undergoing same day,
lower extremity surgery involving the use of a tourniquet with a minimal surgical time of 60
minutes. Subjects will be recruited on the day of surgery, after consultation with the
primary surgeon as to the use of a tourniquet and the anticipated tourniquet time. Subjects
will be approached while awaiting surgery either on E yellow or Same day Surgery in the
Doctor's Office Complex. The study will be explained. The subject and family members will be
given an opportunity to ask questions and if agreeable the subject will be asked to provide
written consent. Standard American Society of Anesthesiologists monitors will be used
including pulse oximetry, electrocardiogram, and non-invasive blood pressure monitoring.
Both groups will have an infusion running.
The experimental group (n= 40) will have a Dexmedetomidine infusion at 0.5 mcg/kg/hr without
a loading dose. The control group (n= 40) will have an equivalent volume of 0.9% normal
saline infusing.
Induction will commence after the initiation of the infusion and will be identical for both
groups: Midazolam 2mg IV, Fentanyl 1-2 micrograms/kg, Lidocaine 1mg/kg, and Propofol 1.5 to
2 mg/kg. Following induction an appropriately sized Laryngeal Mask Airway (LMA) will be
placed. A second intravenous line (preferably 18Gauge or larger) will be placed in the
opposite upper extremity to collect blood samples. Prior to sampling a waste of
10milliLiters will be withdrawn and later returned to the patient. Anesthesia will be
maintained with isoflurane at a Minimum Alveolar Concentration of 0.8 to 1.2. Mean arterial
pressures that exceeds 130mmHg or >30% above baseline or heart rate(HR)s >110 bpm will first
be treated with additional doses of Fentanyl every two minutes for a total dose of 5mcg/kg.
If there is no response following the total dose of Fentanyl then within two minutes further
treatment with Labetalol consisting of titrated doses starting at 5mg IV. Rescue doses of
Hydralazine up to 20mg are allowed to treat hypertension not responsive to Fentanyl and
Labetalol
Measurements:
The following measurements will be collected. Time 0 : In Operating Room holding area
Baseline MAP, Heart Rate(HR) , and Respiratory Rate (RR) will be recorded A baseline Numeric
Ration Scale Pain Score determined
Time 1: Following Induction and prior and to tourniquet inflation MAP, HR, and RR will be
recorded at five minute intervals throughout the surgical procedure
Blood samples will be analyzed for markers of stress response at four intervals.
Time 1 Following induction and prior to tourniquet inflation
Blood samples will be collected:
- C reactive Protein
- Insulin
- Cortisol
- Glucose Time 2 60 minutes after tourniquet inflation
Blood samples will be collected:
- C reactive Protein
- Insulin
- Cortisol
- Glucose
Time 3 120 minutes after tourniquet inflation or prior to tourniquet release (whichever
occurs first)
Blood samples will be collected:
- C reactive Protein
- Insulin
- Cortisol
- Glucose
Time 4 30 minutes after tourniquet release
Blood samples will be collected:
- C reactive Protein
- Insulin
- Cortisol
- Glucose
Blood (15ml) will be collected from an intravenous line placed after induction of anesthesia
at four time points: (1) (pre-tourniquet placement), (2) 60 minutes following inflation of
the tourniquet and (3 ) 120 minutes after tourniquet inflation, and (4)approximately 30
minutes following tourniquet removal. These specimens will be placed into Vacutainer tubes
with no anti-coagulant. They will be labeled with study name, subject's study ID number,
sample number (1, 2, 3, 4), and date. Bloods from the first three time points will be kept
refrigerated until the final sample is obtained Intra-operatively additional doses of
Fentanyl and doses of Labetalol and Hydralazine will be recorded. The use of a nerve block
will be documented as well.
In the Post Anesthesia Care Unit (PACU), additional doses of pain medication,
anti-hypertensive medications and medications administered for relief of post operative
nausea and vomiting (PONV) will be recorded. Vital signs will be measured for 15 minute
intervals until criteria for discharge is met. A post-operative numeric pain score will be
determined when the subject is ready for PACU discharge. On post operative day one, a follow
up phone call will be made to the subject. He or she will be questioned as to their pain
score and the use of pain medication since discharge.
