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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-08-31

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.

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Detailed Description

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Conditions

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Disorder; Mental, Sedative Pain, Postoperative Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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propofol

these patients are sedated with propofol infusion during ICU admission

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Sedation

dexmedetomidine

these patients are sedated with dexmedetomidine infusion during ICU admission

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Sedation

Interventions

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Propofol

Sedation

Intervention Type DRUG

Dexmedetomidine

Sedation

Intervention Type DRUG

Other Intervention Names

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Propofol-Lipuro Precedex

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No