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

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.

Study Overview

• Status: Unknown
• Conditions: Cirrhosis; Intestinal Fistula; Intestinal Obstruction; Abdominal Tumor; Aneurism
• Intervention / Treatment: Drug: dexmedetomidine; Drug: propofol

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • First affiliated hostipal,Sun Yat-sen University
      • Contact: mingyin chen, MD; Phone Number: 008613925019136; Email: chmy1969@hotmail.com
      • Principal Investigator: mingyin chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Postoperative patients of major abdominal surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: minying chen, MD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (Estimate): August 20, 2012

Study Record Updates

• Last Update Posted (Estimate): August 22, 2012
• Last Update Submitted That Met QC Criteria: August 20, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Digestive System Fistula; Fistula; Aneurysm; Abdominal Neoplasms; Intestinal Obstruction; Intestinal Fistula; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: IRB[2012]260