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

Phase 4

Completed

• Conditions: Surgery; Disorder; Mental, Sedative; Pain, Postoperative
• Interventions: Drug: Dexmedetomidine; Drug: Propofol

• Registration Number: NCT02393066
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2015-03-15
• Study First Posted: 2015-03-19
• Primary Completion: 2015-07
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• non-emergent major abdominal tumor surgery with ICU admission
• the need of sedation during ICU stay

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	Dexmedetomidine	these patients are sedated with dexmedetomidine infusion during ICU admission
propofol	Propofol	these patients are sedated with propofol infusion during ICU admission

Primary Outcome Measures

Name	Time	Method
cardiac index	six hours after recruitment	the cardiac index measured by the Bioreactance-based noninvasive CO measurement (NICOM system) six hours after recruitment

Secondary Outcome Measures

Name	Time	Method
heart rate	six hours after recruitment
mean arterial pressure	six hours after recruitment
stroke volume	six hours after recruitment
urine output	six hours after recruitment

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan