Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I - No loading dose | No loading dose to be administered during the loading-dose paradigms |
| |
| Group II - Loading dose over 10 minutes | Loading dose dexmedetomidine 1 mcg/kg administered over 10 minutes during the loading-dose paradigms |
| |
| Group III - Loading dose over 20 minutes | Loading dose dexmedetomidine 1 mcg/kg administered over 20 minutes during the loading-dose paradigms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinically meaningful hemodynamic abnormality (CMHA) | Clinically meaningful hemodynamic abnormalities (CMHA) consist of (any):
| During the first 2 hours of study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Adverse events including agitation/anxiety, cardiac dysrhythmias, rebound phenomenon, and signs of withdrawal |
Not provided
Inclusion Criteria:
Subject or the subject's legally authorized representative has voluntarily signed and dated the informed consent document approved by the Research Ethics Board (REB).
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.
Has an American Society of Anesthesiologist (ASA) classification of 1, 2, 3 or 4.
ASA Physical Status Classification System
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Initially intubated and mechanically ventilated post-surgical adult male and female subjects in an intensive care setting.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre, University of Calgary | Calgary | Alberta | T2N 2T9 | Canada | ||
| University of Alberta Hospital, Department of Anesthesiology and Pain Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
| Post-dexmedetomidine 24-hour observation period |
| Incidence of paradoxical hypertension | During the first 2 hours of the post-dexmedetomidine observation period |
| Incidence of paradoxical hypertension | Post-dexmedetomidine 24-hour 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 |
| Edmonton |
| Alberta |
| T6G 2G3 |
| Canada |
| Red Deer Regional Hospital Centre, Alberta Health Services | Red Deer | Alberta | T4N 4E7 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Capital Health-Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | 63H 3A7 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| St. Mary's General Hospital | Kitchener | Ontario | N2M 1B2 | Canada |
| University Hospital | London | Ontario | N6A5A5 | Canada |
| Thunder Bay | Ontario | P7B 7C7 | Canada |
| Department of Anesthesia, St. Michael's Hospital | Toronto | Ontario | M56 1W8 | Canada |
| Toronto General Hospital, University Health Network, Department of Anesthesia and Pain Management | Toronto | Ontario | M5G 2C4 | Canada |
| McGill University Health Centre (MUHC) Royal Victoria Hospital (RVH) | Montreal | Quebec | H3A 1A1 | Canada |
| McGill University Health Centre, Montreal General Hospital (MGH) | Montreal | Quebec | H3G 1A4 | Canada |
| Sir Mortimer B. Davis Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Universite de Sherbrooke | Sherbrooke | Quebec | J1H SN4 | Canada |
| Département d'anesthésiologie, Institut universitaire de cardiologie et de pneumologie de Québec | Québec | G1V 4G5 | Canada |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided