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Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients

Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01669044
Enrollment
80
Registered
2012-08-20
Start date
2012-05-31
Completion date
2012-12-31
Last updated
2012-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Tumor, Aneurism, Cirrhosis, Intestinal Fistula, Intestinal Obstruction

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.

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.

Interventions

DRUGdexmedetomidine

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.

DRUGpropofol

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.

Sponsors

First Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Postoperative patients of major abdominal surgery 2. Age ≧ 18

Exclusion criteria

1. heart rate ≤ 50 bpm 2. allergy with dexmedetomidine or propofol 3. pregnancy

Design outcomes

Primary

MeasureTime frame
Cardiac outputthe study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours

Secondary

MeasureTime frame
Stroke Volumethe study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours

Other

MeasureTime frame
Systemic Venous Resistance Indexthe study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours

Countries

China

Contacts

Primary Contactmingyin chen, MD
chmy1969@hotmail.com008613925019136

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026