Comparison of Hemodynamics Between Dexmedetomidine and Propofol for Sedation in Patients With Abdominal Surgery
Primary Purpose
Disorder; Mental, Sedative, Pain, Postoperative, Surgery
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Propofol
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Disorder; Mental, Sedative
Eligibility Criteria
Inclusion Criteria:
- non-emergent major abdominal tumor surgery with ICU admission
- the need of sedation during ICU stay
Exclusion Criteria:
- age older than 99 years
- age younger than 20 years
- refractory arrhythmias
- refractory shock status after resuscitation
- new onset of myocardial infarction
- severe heart failure or NYHA 4
- APACHE score > 30 when recruiting
- severe liver cirrhosis or CHILD B or C
- organ transplantation within one year
- pregnancy
- allergic to propofol or dexmedetomidine
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
propofol
dexmedetomidine
Arm Description
these patients are sedated with propofol infusion during ICU admission
these patients are sedated with dexmedetomidine infusion during ICU admission
Outcomes
Primary Outcome Measures
cardiac index
the cardiac index measured by the Bioreactance-based noninvasive CO measurement (NICOM system) six hours after recruitment
Secondary Outcome Measures
mean arterial pressure
heart rate
stroke volume
urine output
Full Information
NCT ID
NCT02393066
First Posted
October 27, 2014
Last Updated
August 3, 2015
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02393066
Brief Title
Comparison of Hemodynamics Between Dexmedetomidine and Propofol for Sedation in Patients With Abdominal Surgery
Official Title
A Comparison of Hemodynamic Effects Between Dexmedetomidine and Propofol for Sedation in Patients With Major Abdominal Tumor Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single-blind randomized clinical trial. Patients undergoing abdominal tumor surgery were recruited to participate in the study. Apart from routine treatment in the surgical intensive care unit, the subjects were randomly divided into two groups: Propofol group (Group P) and Dexmedetomidine group (Group D) and received continuous intravenous infusion of Propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h) or Dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h) according to their assigned group. Patients' hemodynamic status was monitored using a chest Bioreactance technique, Continuous Non-Invasive Cardiac Output and Hemodynamic Monitor at preset time points (time of recruitment [0h], 2, 4, 6, 12h and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results, fluid volume and drugs used were also recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder; Mental, Sedative, Pain, Postoperative, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
propofol
Arm Type
Active Comparator
Arm Description
these patients are sedated with propofol infusion during ICU admission
Arm Title
dexmedetomidine
Arm Type
Active Comparator
Arm Description
these patients are sedated with dexmedetomidine infusion during ICU admission
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Propofol-Lipuro
Intervention Description
Sedation
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Sedation
Primary Outcome Measure Information:
Title
cardiac index
Description
the cardiac index measured by the Bioreactance-based noninvasive CO measurement (NICOM system) six hours after recruitment
Time Frame
six hours after recruitment
Secondary Outcome Measure Information:
Title
mean arterial pressure
Time Frame
six hours after recruitment
Title
heart rate
Time Frame
six hours after recruitment
Title
stroke volume
Time Frame
six hours after recruitment
Title
urine output
Time Frame
six hours after recruitment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-emergent major abdominal tumor surgery with ICU admission
the need of sedation during ICU stay
Exclusion Criteria:
age older than 99 years
age younger than 20 years
refractory arrhythmias
refractory shock status after resuscitation
new onset of myocardial infarction
severe heart failure or NYHA 4
APACHE score > 30 when recruiting
severe liver cirrhosis or CHILD B or C
organ transplantation within one year
pregnancy
allergic to propofol or dexmedetomidine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chang Yeh, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Comparison of Hemodynamics Between Dexmedetomidine and Propofol for Sedation in Patients With Abdominal Surgery
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