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Comparison Between Dexmedetomidine and Propofol for Patients in the Intensive Care Unit After Abdominal Surgery

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02874768
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
23.6
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-blind randomized clinical trial. Patients undergoing abdominal surgery will be enrolled and randomly divided into two groups: dexmedetomidine group and propofol group. In the dexmedetomidine group, patients will receive continuous intravenous infusion of dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h). In the propofol group, patients will receive continuous intravenous infusion of propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h). Hemodynamics will be continuously monitored using a non-invasive monitoring with chest bioreactance technique at preset time points (0, 2, 4, 6, 12h and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results and fluid balance will be recorded. The microcirculation will be examined by Cytocam. The following microcirculatory parameters will be investigated: total small vessel density, perfused small vessel density, microvascular flow index, and heterogeneity index. The enzyme-linked immunosorbent assays will be used to measure serum level of endocan, diamine oxidase, and neutrophil gelatinase-associated lipocalin at preset time points. The primary goal of this study is to compare the effect on microcirculation between dexmedetomidine and propofol in intensive care unit patients after abdominal surgery.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Comparison Between Dexmedetomidine and Propofol for Postoperative Sedation of Patients in the Intensive Care Unit After Abdominal Surgery: Microcirculation, Kidney Injury, and Intestinal Injury
Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Jul 20, 2018
Actual Study Completion Date :
Jul 20, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: dexmedetomidine

Patient receives continuous intravenous infusion of dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h)

Drug: Dexmedetomidine
Patient receives continuous intravenous infusion of dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h)
Other Names:
  • Precedex

    		•
    Active Comparator: Propofol

    Patient receives continuous intravenous infusion of propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h)

    Drug: Propofol
    Patient receives continuous intravenous infusion of propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h)
    Other Names:
  • Fresofol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total perfused small vessel density [6 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • non-emergent major abdominal surgery with ICU admission

    • the need of sedation during ICU stay

    Exclusion Criteria:

    • age younger than 20 years and older than 89 years

    • refractory bradycardia (HR < 60 bpm after treatment)

    • severe AV block (2nd or 3rd degree)

    • refractory shock (MAP < 60 mm Hg after treatment)

    • severe heart failure or NYHA 4

    • new onset of myocardial infarction within 4 weeks

    • receive CPR within 4 weeks

    • APACHE score > 30 before enrollment

    • severe liver cirrhosis or CHILD B or C

    • pregnancy

    • allergic history to dexmedetomidine or propofol

    • be enrolled in other clinical trials related to dexmedetomidine or propofol within 4 weeks

    • non-native speakers

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Study Chair: Yu-Chang Yeh, PhD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT02874768
    Other Study ID Numbers:
    • 201605038MINB
    First Posted:
    Aug 22, 2016
    Last Update Posted:
    Mar 4, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Dexmedetomidine
    Propofol

    Study Results

    No Results Posted as of Mar 4, 2019