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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393066
• Other study ID #: 201407023MINA
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2014
• Last updated: August 3, 2015
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder; Mental, Sedative
• Mental Disorders
• Pain, Postoperative
• Surgery

Intervention

Drug:
• Propofol
Sedation
• Dexmedetomidine
Sedation

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac index	the cardiac index measured by the Bioreactance-based noninvasive CO measurement (NICOM system) six hours after recruitment	six hours after recruitment	No
Secondary	mean arterial pressure		six hours after recruitment	No
Secondary	heart rate		six hours after recruitment	No
Secondary	stroke volume		six hours after recruitment	No
Secondary	urine output		six hours after recruitment	No