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

• Conditions: Abdominal Tumor; Intestinal Obstruction; Cirrhosis; Intestinal Fistula; Aneurism
• Interventions: Drug: dexmedetomidine; Drug: propofol

• Registration Number: NCT01669044
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2012-05
• Status Verified: 2012-08
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-20
• Last Update Submitted: 2012-08-20
• Last Update Posted: 2012-08-22
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
dexmedetomidine,hemodynamics,injection	dexmedetomidine	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.
propofol,hemodynamics,injection	propofol	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Stroke Volume	the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours

Trial Locations

Locations (1)

First affiliated hostipal,Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China