Orthopedic/Podiatry ProceduresPhase 4NCT00932386
Effects of Dexmedetomidine on Tourniquet Pain Associated With Lower Extremity Surgeries Under General Anesthesia
A Phase 4 study testing Dexmedetomidine Hcl infusion and normal saline in people with Orthopedic/Podiatry Procedures, run by Rutgers, The State University of New Jersey at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orthopedic/Podiatry Procedures
- What is being tested?
- Dexmedetomidine Hcl infusion and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing lower extremity surgery which requires the use of an inflated tourniquet ASA rating I-III
Who cannot join
- Allergy to alpha 2 adrenergic agonists
- Uncontrolled hypertension (SBP>180mm HG, Diastolic Blood Pressure >110mmHG)
- Heart block greater than first degree or cardiac muscle at risk for reversible ischemia
- Airway anatomy that contra-indicates the use of a laryngeal airway mask expected tourniquet time less than 60 minutes or greater than 150 minutes
- Subjects who do not have a phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Dexmedetomidine on Tourniquet Pain Associated With Lower Extremity Surgeries Under General Anesthesia in Same Day Elective Patients
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.
Read the detailed 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.
- Conditions
- Orthopedic/Podiatry Procedures
- Being tested
- Dexmedetomidine Hcl infusion, normal saline
- Keywords
- Lower extremity surgery with tourniquet use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Hcl infusionDrug
Also called Precedex
0.5mcg/kg/hr
normal salineDrug
0.9% normal saline infusing
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine Hcl infusion | Experimental | Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist, which possesses hypnotic, sedative, anxiolytic, sympatholytic and analgesic properties. Receives: Drug: Dexmedetomidine Hcl infusion |
| normal saline | Placebo comparator | Not described Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic stability
Measured: mean arterial pressure, heart rate and respiratory rate prior to surgery and at 5 minute intervals during surgery. same assessment in PACU until ready for discharge from PACU
Secondary outcomes (1)
markers for stress response
Measured: prior to tourniquet inflation, 60 minutes after tourniquet inflation, 120 minutes after tourniquet inflation and 30 minutes after tourniquet release.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2011 (estimated)
Why it stopped: unable to secure funding for analysis of laboratory data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic/Podiatry ProceduresStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay S Berger, MD, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932386
- Sponsor's protocol ID
- 0120090056
- Status last verified
- Apr 2015
- First submitted
- 1 Jul 2009
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexmedetomidine on Tourniquet Pain Associated With Lower Extremity Surgeries Under General Anesthesia in Same Day Elective Patients
- ClinicalTrials.gov ID
- NCT00932386
- Acronym / sponsor ID
- 0120090056
- Conditions
- Orthopedic/Podiatry Procedures
- Keywords
- Lower extremity surgery with tourniquet use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to secure funding for analysis of laboratory data.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (estimated)
- First posted
- 3 Jul 2009 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine Hcl infusion | Experimental | Drug: Dexmedetomidine Hcl infusionDexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist, which possesses hypnotic, sedative, anxiolytic, sympatholytic and analgesic properties. |
| normal saline | Placebo comparator | Drug: normal saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing lower extremity surgery which requires the use of an inflated tourniquet ASA rating I-III
Key exclusion criteria (5 listed)
- Allergy to alpha 2 adrenergic agonists
- Uncontrolled hypertension (SBP>180mm HG, Diastolic Blood Pressure >110mmHG)
- Heart block greater than first degree or cardiac muscle at risk for reversible ischemia
- Airway anatomy that contra-indicates the use of a laryngeal airway mask expected tourniquet time less than 60 minutes or greater than 150 minutes
- Subjects who do not have a phone
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 |
|---|---|---|
| Dexmedetomidine Hcl infusionAlso: Precedex0.5mcg/kg/hr | Drug | dexmedetomidine Hcl infusion |
| normal saline0.9% normal saline infusing | Drug | normal saline |
Primary outcome
hemodynamic stability
Time frame: mean arterial pressure, heart rate and respiratory rate prior to surgery and at 5 minute intervals during surgery. same assessment in PACU until ready for discharge from PACU
1 secondary outcome
markers for stress response
Time frame: prior to tourniquet inflation, 60 minutes after tourniquet inflation, 120 minutes after tourniquet inflation and 30 minutes after tourniquet release.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
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.
Jay S Berger, MD, PhD principal investigator
Rutgers, The State University of New Jersey
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 Hcl infusion and normal saline in people with Orthopedic/Podiatry Procedures, run by Rutgers, The State University of New Jersey 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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 24 Apr 2015. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
hemodynamic stability (time frame: mean arterial pressure, heart rate and respiratory rate prior to surgery and at 5 minute intervals during surgery. same assessment in PACU until ready for discharge from PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2015.