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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Minying Chen, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01669044
First received: August 16, 2012
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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 Intervention
Abdominal Tumor
Intestinal Obstruction
Cirrhosis
Intestinal Fistula
Aneurism
Drug: dexmedetomidine
Drug: propofol

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 16, 2012
Last Updated: August 20, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Abdominal Neoplasms
Intestinal Fistula
Intestinal Obstruction
Digestive System Diseases
Digestive System Fistula
Fistula
Gastrointestinal Diseases
Intestinal Diseases
Neoplasms
Neoplasms by Site
Pathological Conditions, Anatomical
Dexmedetomidine
Propofol
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014