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

This study has been withdrawn prior to enrollment.
(unable to secure funding for analysis of laboratory data.)
Sponsor:
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00932386
First received: July 1, 2009
Last updated: May 6, 2010
Last verified: May 2010
History of Changes
  Purpose

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 Intervention Phase
Orthopedic/Podiatry Procedures
 Drug: Dexmedetomidine Hcl infusion
Drug: normal saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2009
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
0.5mcg/kg/hr
Other Name: Precedex
Placebo Comparator: normal saline Drug: normal saline
0.9% normal saline infusing

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, DBP >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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932386

Locations
United States, New Jersey
New Jersey Medical School
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Jay S Berger, MD, PhD University of Medicine and Dentistry New Jersey
  More Information

No publications provided

Responsible Party: Jay S. Berger, MD PhD, University of Medicine & Dentistry of New jersey
ClinicalTrials.gov Identifier: NCT00932386     History of Changes
Other Study ID Numbers: 0120090056
Study First Received: July 1, 2009
Last Updated: May 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
Lower extremity surgery with tourniquet use

Additional relevant MeSH terms:
Anesthetics
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Non-Narcotic
 Analgesics
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

ClinicalTrials.gov processed this record on May 22, 2013