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

NCT02393066 | Completed Phase 4

• 1 other identifier: 201407023MINA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder; Mental, Sedative; Pain, Postoperative; Surgery

Outcome Measures

Primary Outcomes (1)

• cardiac index

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

  six hours after recruitment

Secondary Outcomes (4)

• mean arterial pressure

  six hours after recruitment

• heart rate

  six hours after recruitment

• stroke volume

  six hours after recruitment

• urine output

  six hours after recruitment

Study Arms (2)

propofol

ACTIVE COMPARATOR

these patients are sedated with propofol infusion during ICU admission

Drug: Propofol

dexmedetomidine

ACTIVE COMPARATOR

these patients are sedated with dexmedetomidine infusion during ICU admission

Drug: Dexmedetomidine

Interventions

Propofol DRUG

Sedation

Also known as: Propofol-Lipuro

propofol

Dexmedetomidine DRUG

Sedation

Also known as: Precedex

dexmedetomidine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-emergent major abdominal tumor surgery with ICU admission
• the need of sedation during ICU stay

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yu-Chang Yeh, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: March 19, 2015
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

TW (1)