Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients undergoing thoracic surgery after discharge from PACU or ICU.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) class I, II or III

• Undergoing thoracic surgery on an inpatient basis

• Age 18 up to 85 years of age

Exclusion Criteria:

• Subject is pregnant and/or lactating

• Subject has a serious Central Nervous System (CNS)pathology/trauma that, per clinical judgment of the investigator, precludes responsiveness or survival.

• Subject for whom alpha-2 agonists are contraindicated

• Subject meets any of the following cardiovascular criteria:

• Acute unstable angina (defined during current hospital stay)

• Suspicion of acute myocardial infarction.

• Considered to have a left ventricular ejection fraction of less than 30%.Decision to exclude is predicated in the Investigator's opinion, and may be based on any combination of acute presentations, recently preformed diagnostic studies, or a history that suggests poor cardiac function. Pulmonary congestion of a non-cardiac origin or mild congestive failure primarily attributable to etiologies other than poor ventricular function are not exclusion criteria.

• Subject has participated in a trial with any experimental drug within 30 days prior to enrollment in the study, or has ever been enrolled in this study.

• Subject is unable to undergo any procedures required by the protocol.

• Subject has acute hepatitis, a history or presence of chronic hepatitis, and /or has had a positive result for Hepatitis B surface antigen test.

• Subject requires dialysis (e.g., hemodialysis, peritoneal dialysis, CVVHD).

• Subject has a known, uncontrolled seizure disorder.

• Subject has a known psychiatric illness that could confound a normal response to sedative treatment.

• Subject is terminally ill with a life duration expectancy of < 60 days.

• Subject has a history of Obstructive Sleep Apnea.

• Oxygen saturation is < 90% on room air.

• Subject is on beta blocker medication.