Skip to content

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

Comparison Between Dexmedetomidine and Propofol for Postoperative Sedation of Patients in the Intensive Care Unit After Abdominal Surgery: Microcirculation, Kidney Injury, and Intestinal Injury

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02874768
Enrollment
60
Registered
2016-08-22
Start date
2016-08-31
Completion date
2018-07-20
Last updated
2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microcirculation

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.

Interventions

DRUGDexmedetomidine

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

DRUGPropofol

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 89 Years
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

Design outcomes

Primary

MeasureTime frame
Total perfused small vessel density6 hours

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026