Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients
Study Details
Study Description
Brief Summary
The alpha2 agonist dexmedetomidine is a new sedative agent combined with the analgesic qualities and lack of respiratory depression. Patients sedated with dexmedetomidine could be easily roused, these advances shows dexmedetomidine may be a effective and safe sedative agent. But some studies showed some adversely effects of dexmedetomidine on haemodynamics (such as bradycardia, hypotension), the investigators want to further research the effects of dexmedetomidine on haemodynamics, such as Cardiac Output (CO), Systemic Venous Resistance Index(SVRI), and so on. Propofol is widely used sedative agent in ICU, it also has adversely effects like bradycardia and hypotension, so the investigators want to compare the effect of dexmedetomidine with propofol on haemodynamics after major abdominal surgery. Expect to further research the mechanism of haemodynamics of dexmedetomidine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
When the patients can be roused, they will first receive analgesia with bolus of fentanyl 0.03mg, followed by a continuous infusion at a fixed dose of 0.3μg/kg/h during study period. Then patients will be randomly divided into two groups (Dexmedetomidine and Propofol). All of them will receive hemodynamic monitoring through "Vigileo"(Edwards Lifesciences) and cardiogram monitor. The study will continue for 6-24 hours.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| dexmedetomidine,hemodynamics,injection Group 1:when the patient can be roused after major abdominal surgery ，we will inject dexmedetomidine at 1μg/kg in 10 minutes as a loading dose, followed by a continuous infusion at 0.3μg/kg/h for 6 to 24hours.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores. |
Drug: dexmedetomidine
dexmedetomidine: IV (in the vein)at 1μg/kg in 10 minutes as a loading dose, followed by a continuous infusion at 0.3μg/kg/h.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.
|
| propofol,hemodynamics,injection Group 2 :when the patient can be roused after major abdominal surgery ，we will inject propofol at 0.5mg/kg as a loading dose, followed by a continuous infusion at 0.5mg/kg.h for 6 to 24hours.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores |
Drug: propofol
propofol: IV (in the vein)at 0.5mg/kg as a loading dose, followed by a continuous infusion at 0.5mg/kg/h.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.
|
Outcome Measures
Primary Outcome Measures
- Cardiac output [the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours]
Secondary Outcome Measures
- Stroke Volume [the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours]
Other Outcome Measures
- Systemic Venous Resistance Index [the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Postoperative patients of major abdominal surgery
-
Age ≧ 18
Exclusion Criteria:
-
heart rate ≤ 50 bpm
-
allergy with dexmedetomidine or propofol
-
pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First affiliated hostipal,Sun Yat-sen University | Guangzhou | Guangdong | China | 510080 |
Sponsors and Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
Investigators
- Principal Investigator: minying chen, MD, study principal investigator
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB[2012]260