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

Microcirculation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02874768
• Other study ID #: 201605038MINB
• Status: Completed
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: July 20, 2018

Study information

• Verified date: February 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Microcirculation

Intervention

Drug:
• Dexmedetomidine
Patient receives continuous intravenous infusion of dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h)
• Propofol
Patient receives continuous intravenous infusion of propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total perfused small vessel density		6 hours