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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01169571
Other study ID # DEX-10-03
Secondary ID
Status Completed
Phase N/A
First received July 21, 2010
Last updated July 23, 2015
Start date September 2010
Est. completion date June 2011

Study information

Verified date July 2015
Source Hospira, Inc.
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 373
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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).

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine


Locations

Country Name City State
Canada Foothills Medical Centre, University of Calgary Calgary Alberta
Canada University of Alberta Hospital, Department of Anesthesiology and Pain Medicine Edmonton Alberta
Canada Capital Health-Queen Elizabeth II Health Sciences Center Halifax Nova Scotia
Canada Kingston General Hospital Kingston Ontario
Canada St. Mary's General Hospital Kitchener Ontario
Canada University Hospital London Ontario
Canada McGill University Health Centre (MUHC) Royal Victoria Hospital (RVH) Montreal Quebec
Canada McGill University Health Centre, Montreal General Hospital (MGH) Montreal Quebec
Canada Sir Mortimer B. Davis Jewish General Hospital Montreal Quebec
Canada Département d'anesthésiologie, Institut universitaire de cardiologie et de pneumologie de Québec Quebec
Canada Red Deer Regional Hospital Centre, Alberta Health Services Red Deer Alberta
Canada Universite de Sherbrooke Sherbrooke Quebec
Canada Department of Anesthesia, St. Michael's Hospital Toronto Ontario
Canada Toronto General Hospital, University Health Network, Department of Anesthesia and Pain Management Toronto Ontario
Canada St. Paul's Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
Hospira, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of clinically meaningful hemodynamic abnormality (CMHA) 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.
During the first 2 hours of study drug administration Yes
Secondary Incidence of clinically meaningful hemodynamic abnormality (CMHA) during the maintenance infusion period. Maintenance infusion period (2 to 24 hours) Yes
Secondary Incidence of adverse events (AEs) between the 3 loading-dose paradigms Adverse events including agitation/anxiety, cardiac dysrhythmias, rebound phenomenon, and signs of withdrawal Post-dexmedetomidine 24-hour observation period Yes
Secondary Incidence of paradoxical hypertension During the first 2 hours of the post-dexmedetomidine observation period Yes
Secondary Incidence of paradoxical hypertension Post-dexmedetomidine 24-hour observation period Yes
Secondary Amount of analgesics administered 2 hours prior, and for the first 2 hours during, study drug administration Yes
Secondary Amount of sedatives administered 2 hours prior, and for the first 2 hours during, study drug administration Yes
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