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

NCT ID: NCT02874768

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-07-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

dexmedetomidine

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

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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)

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

Propofol

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

Intervention Type: DRUG

Other Intervention Names

Precedex; Fresofol

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Chang Yeh, PhD

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201605038MINB

Identifier Type: -

Identifier Source: org_study_id