Comparison of Hemodynamics Between Dexmedetomidine and Propofol for Sedation in Patients With Abdominal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Comparison of Hemodynamic Effects Between Dexmedetomidine and Propofol for Sedation in Patients With Major Abdominal Tumor Surgery

Conditions
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Disorder; Mental, Sedative, Pain, Postoperative, Surgery

Intervention / Treatment
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* Drug: Propofol
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol<br>these patients are sedated with propofol infusion during ICU admission | Drug: Propofol<br>* Sedation<br>* Other names: Propofol-Lipuro;|
| Active Comparator: dexmedetomidine<br>these patients are sedated with dexmedetomidine infusion during ICU admission | Drug: Dexmedetomidine<br>* Sedation<br>* Other names: Precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac index | the cardiac index measured by the Bioreactance-based noninvasive CO measurement (NICOM system) six hours after recruitment | six hours after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial pressure |  | six hours after recruitment | 
| heart rate |  | six hours after recruitment | 
| stroke volume |  | six hours after recruitment | 
| urine output |  | six hours after recruitment |