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Effects of Dexmedetomidine on Tourniquet Pain Associated With Lower Extremity Surgeries Under General Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00932386
Recruitment Status : Withdrawn (unable to secure funding for analysis of laboratory data.)
First Posted : July 3, 2009
Last Update Posted : April 24, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Orthopedic/Podiatry Procedures Drug: Dexmedetomidine Hcl infusion Drug: normal saline Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Dexmedetomidine on Tourniquet Pain Associated With Lower Extremity Surgeries Under General Anesthesia in Same Day Elective Patients
Study Start Date : July 2009
Estimated Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: dexmedetomidine Hcl infusion
Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist, which possesses hypnotic, sedative, anxiolytic, sympatholytic and analgesic properties.
Drug: Dexmedetomidine Hcl infusion
Other Name: Precedex
Placebo Comparator: normal saline Drug: normal saline
0.9% normal saline infusing

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients undergoing lower extremity surgery which requires the use of an inflated tourniquet ASA rating I-III

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932386

United States, New Jersey
New Jersey Medical School
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Principal Investigator: Jay S Berger, MD, PhD Rutgers, The State University of New Jersey
More Information

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00932386     History of Changes
Other Study ID Numbers: 0120090056
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Keywords provided by Rutgers, The State University of New Jersey:
Lower extremity surgery with tourniquet use

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action