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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01669044
• Other study ID #: IRB[2012]260
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2012
• Last updated: August 20, 2012
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: mingyin chen, MD
• Phone: 008613925019136
• Email: chmy1969[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Neoplasms
• Abdominal Tumor
• Aneurism
• Cirrhosis
• Intestinal Fistula
• Intestinal Obstruction

Intervention

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
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.

Locations

Country	Name	City	State
China	First affiliated hostipal,Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	Cardiac output		the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours	Yes
Secondary	Stroke Volume		the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours	Yes