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NCT Number: NCT02874768

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

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.

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Key information

Conditions

Age range

20 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

Propofol

Drug

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

Other names: Fresofol

Primary outcomes

  1. Total perfused small vessel density

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2016
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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