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

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ClinicalTrials.gov Identifier: NCT01669044
Recruitment Status : Unknown
Verified August 2012 by Minying Chen, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : August 20, 2012
Last Update Posted : August 22, 2012
Sponsor:
Information provided by (Responsible Party):
Minying Chen, 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.

Condition or disease Intervention/treatment
Abdominal Tumor Intestinal Obstruction Cirrhosis Intestinal Fistula Aneurism 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
Estimated Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients
Study Start Date : May 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Postoperative patients of major abdominal surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669044


Contacts
Contact: mingyin chen, MD 008613925019136 chmy1969@hotmail.com

Locations
China, Guangdong
First affiliated hostipal,Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: mingyin chen, MD    008613925019136    chmy1969@hotmail.com   
Principal Investigator: mingyin chen, MD         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Principal Investigator: minying chen, MD study principal investigator

Responsible Party: Minying Chen, MD, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01669044     History of Changes
Other Study ID Numbers: IRB[2012]260
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Aneurysm
Fistula
Intestinal Obstruction
Abdominal Neoplasms
Intestinal Fistula
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neoplasms by Site
Neoplasms
Digestive System Fistula
Propofol
Dexmedetomidine
Benzocaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists