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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Post-operative Pain, Respiratory Depression

In brief

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.

Key facts

Study ID

NCT00345384

Run by

Baylor Research Institute

People needed

38

Starts

2008-05-01

Expected to finish

2010-01-01

Last updated by the study team

2016-02-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Baylor University Medical Center - Department of Anesthesiology — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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