Intensive Care Unit
Conditions
Keywords
Initially intubated, Mechanically ventilated, Post-surgical
Brief summary
The objective of this study is to characterize the hemodynamic effects of Precedex (dexmedetomidine (DEX)) during 3 loading-dose paradigms in mechanically ventilated post-surgical subjects in an intensive care setting.
Interventions
DRUGDexmedetomidine
Sponsors
Hospira, now a wholly owned subsidiary of Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject or the subject's legally authorized representative has voluntarily signed and dated the informed consent document approved by the Research Ethics Board (REB). 2. Initially intubated and mechanically ventilated adult post-operative subjects in an intensive care setting (e.g., post operative care unit, post anesthesia care unit, etc.) that are expected to require sedation for at least 2 hours. 3. Has an American Society of Anesthesiologist (ASA) classification of 1, 2, 3 or 4. ASA Physical Status Classification System * P1 A normal healthy subject * P2 A subject with mild systemic disease * P3 A subject with severe systemic disease * P4 A subject with severe systemic disease that is a constant threat to life * P5 A moribund subject who is not expected to survive without the operation * P6 A declared brain-dead subject whose organs are being removed for donor purposes. 4. If female, subject must be postmenopausal, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control: * hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration * intrauterine device (IUD) * double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
Exclusion criteria
1. Subjects \<18 years of age. 2. Subjects with a 2nd degree Mobitz Type II or 3rd degree heart block, unless the subject has a permanent pacemaker or pacing wires are in situ. 3. Subjects with a known allergy to dexmedetomidine. 4. Hypotension based on repeat assessments prior to (within 15 minutes) starting study drug defined as Systolic BP \<90 mmHg or Diastolic BP \<60 mmHg. 5. Pre-existing bradycardia prior (within 15 minutes) to starting study drug defined as HR \<50 bpm. 6. Subjects who, in the opinion of the Investigator, have any other condition where the risks of dexmedetomidine would be expected to outweigh its benefits (e.g., cardiogenic shock on \>2 vasopressors, death anticipated within 48 hours).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinically meaningful hemodynamic abnormality (CMHA) | During the first 2 hours of study drug administration | Clinically meaningful hemodynamic abnormalities (CMHA) consist of (any): * Heart Rate (HR): A native HR \<40 bpm (beats per minute); HR \<50 bpm requiring pharmacological intervention; systolic BP \<80 mm Hg; if pacing wires are in situ, use of a pacemaker after the start of study drug. * Vasoactive Agent Use (i.e. vasopressor or inotrope): the need to add an additional agent to maintain BP; doubling of the dose of any vasoactive agent that was infusing at the start of the study drug. * Paradoxical hypertension: the need to add an additional vasodilating agent for control of hypertension; doubling of the dose of any vasodilating agent that was infusing at the start of the study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinically meaningful hemodynamic abnormality (CMHA) during the maintenance infusion period. | Maintenance infusion period (2 to 24 hours) | — |
| Incidence of adverse events (AEs) between the 3 loading-dose paradigms | Post-dexmedetomidine 24-hour observation period | Adverse events including agitation/anxiety, cardiac dysrhythmias, rebound phenomenon, and signs of withdrawal |
| Incidence of paradoxical hypertension | During the first 2 hours of the post-dexmedetomidine observation period | — |
| Amount of analgesics administered | 2 hours prior, and for the first 2 hours during, study drug administration | — |
| Amount of sedatives administered | 2 hours prior, and for the first 2 hours during, study drug administration | — |
Countries
Canada
Outcome results
None listed