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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02393066
Enrollment
60
Registered
2015-03-19
Start date
2014-10-31
Completion date
2015-08-31
Last updated
2015-08-05

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

Conditions

Disorder; Mental, Sedative, Pain, Postoperative, Surgery

Brief summary

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.

Interventions

DRUGPropofol

Sedation

DRUGDexmedetomidine

Sedation

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
mean arterial pressuresix hours after recruitment
heart ratesix hours after recruitment
stroke volumesix hours after recruitment
urine outputsix hours after recruitment

Countries

Taiwan

Outcome results

None listed

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