Skip to main content
OpenTrials
Completed

NCT Number: NCT02393066

Comparison of Hemodynamics Between Dexmedetomidine and Propofol for Sedation in Patients With Abdominal Surgery

This is a single-blind randomized clinical trial. Patients undergoing abdominal tumor surgery were recruited to participate in the study. Apart from routine treatment in the surgical intensive care unit, the subjects were randomly divided into two groups: Propofol group (Group P) and Dexmedetomidine group (Group D) and received continuous intravenous infusion of Propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h) or Dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h) according to their assigned group. Patients' hemodynamic status was monitored using a chest Bioreactance technique, Continuous Non-Invasive Cardiac Output and Hemodynamic Monitor at preset time points (time of recruitment [0h], 2, 4, 6, 12h and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results, fluid volume and drugs used were also recorded.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Disorder; Mental, Sedative Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgery

Age range

20 year and older

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 tumor surgery with ICU admission
  • the need of sedation during ICU stay

Exclusion criteria

  • age older than 99 years
  • age younger than 20 years
  • refractory arrhythmias
  • refractory shock status after resuscitation
  • new onset of myocardial infarction
  • severe heart failure or NYHA 4
  • APACHE score > 30 when recruiting
  • severe liver cirrhosis or CHILD B or C
  • organ transplantation within one year
  • pregnancy
  • allergic to propofol or dexmedetomidine

Treatment and study plan

Propofol

Drug

Sedation

Other names: Propofol-Lipuro

Dexmedetomidine

Drug

Sedation

Other names: Precedex

Primary outcomes

  1. cardiac index

    Time frame: six hours after recruitment

    the cardiac index measured by the Bioreactance-based noninvasive CO measurement (NICOM system) six hours after recruitment

Secondary outcomes

  1. mean arterial pressure

    Time frame: six hours after recruitment

  2. heart rate

    Time frame: six hours after recruitment

  3. stroke volume

    Time frame: six hours after recruitment

  4. urine output

    Time frame: six hours after recruitment

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

A Comparison of Hemodynamic Effects Between Dexmedetomidine and Propofol for Sedation in Patients With Major Abdominal Tumor Surgery

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2015
Registry last updated
Aug 5, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.