Phase 2
Completed N=38
Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients
Post-operative Pain · Depression
Source: ClinicalTrials.gov NCT00345384 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. — 49; 29; 54; 35 IV morphine equivalency in mg — p=0.03
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. |
49; 29; 54; 35 | 0.03 sig |
| SECONDARY Measure the Amount of Respiratory Depression in Each Groups |
45; 42 | 0.02 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00345384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.