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

NCT02874768 | Completed Phase 4

• 1 other identifier: 201605038MINB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Microcirculation

Outcome Measures

Primary Outcomes (1)

• Total perfused small vessel density

  6 hours

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

dexmedetomidine

Propofol DRUG

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

Also known as: Fresofol

Propofol

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Yu-Chang Yeh, PhD

  National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 22, 2016
• Study Start: August 1, 2016
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: March 4, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)