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

NCT00932386 | Withdrawn Phase 4

• 1 other identifier: 0120090056
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic/Podiatry Procedures

Keywords

Lower extremity surgery with tourniquet use

Outcome Measures

Primary Outcomes (1)

• hemodynamic stability

  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

  prior to tourniquet inflation, 60 minutes after tourniquet inflation, 120 minutes after tourniquet inflation and 30 minutes after tourniquet release.

Study Arms (2)

dexmedetomidine Hcl infusion

EXPERIMENTAL

Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist, which possesses hypnotic, sedative, anxiolytic, sympatholytic and analgesic properties.

Drug: Dexmedetomidine Hcl infusion

normal saline

PLACEBO COMPARATOR

Drug: normal saline

Interventions

Dexmedetomidine Hcl infusion DRUG

0.5mcg/kg/hr

Also known as: Precedex

dexmedetomidine Hcl infusion

normal saline DRUG

0.9% normal saline infusing

normal saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

New Jersey Medical School

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jay S Berger, MD, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 3, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

US (1)