An observational study in Abdominal Tumor, Intestinal Obstruction and Cirrhosis, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-22.
Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Observational
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.
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.
67 studies on the registry are indexed under Abdominal Neoplasms; 18 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 15 observational studies indexed under Abdominal Neoplasms.
Browse Abdominal Neoplasms studies →First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.
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Postoperative patients of major abdominal surgery
Exclusion Criteria:
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
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
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: 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.
Cardiac output
Time frame: the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours
Stroke Volume
Time frame: the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours
Systemic Venous Resistance Index
Time frame: the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours
This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital, Sun Yat-Sen University