The Efficacy and Safety of Accufuser Omnibus® (Elastomeric Infusion Pump); Comparative Clinical Trial

NACompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

July 31, 2014

Study Completion Date

August 31, 2014

Conditions
Upper Gastrointestinal Cancer
Interventions
DEVICE

The domestic PCA equipment 'Accufuser Omnibus®'

"* Subject patient selection: the purpose and method of this research will be explained to the patients who satisfy the exclusion criteria before surgery, and written consent regarding research participation will be obtained.~* Use of PCA equipment by patients is determined by randomization. Regardless of the PCA equipment type, the basal rate and bolus dose are equally set to 2 mL/hr and 2 mL for the entire research period.~* Epidural PCA regime: normal saline added to 0.75% ropivacaine 40 mL and fentanyl 15-20 mcg/kg for a total volume of 100 ml.~* After pretreatment, the chest epidural catheter is mounted in the pretreatment room or operating room. The catheter tip is adjusted to be fixed between T6-7 or T7-8.~* After mounting the catheter, a test dose of 1% lidocaine 3 ml and epinephrine 1:200.000 is injected. Ten minutes later, sensory loss and skin dermatome will be checked using an alcohol swab."

DEVICE

Imported PCA equipment 'Infusor SV®, Baxter, USA'

"* Subject patient selection: the purpose and method of this research will be explained to the patients who satisfy the exclusion criteria before surgery, and written consent regarding research participation will be obtained.~* Use of PCA equipment by patients is determined by randomization. Regardless of the PCA equipment type, the basal rate and bolus dose are equally set to 2 mL/hr and 2 mL for the entire research period.~* Epidural PCA regime: normal saline added to 0.75% ropivacaine 40 mL and fentanyl 15-20 mcg/kg for a total volume of 100 ml.~* After pretreatment, the chest epidural catheter is mounted in the pretreatment room or operating room. The catheter tip is adjusted to be fixed between T6-7 or T7-8.~* After mounting the catheter, a test dose of 1% lidocaine 3 ml and epinephrine 1:200.000 is injected. Ten minutes later, sensory loss and skin dermatome will be checked using an alcohol swab."

Trial Locations (1)

120-752

Departmnent of Anesthesiology and Pain Medicne Severance Hospital, Yonsei University Health System, Seoul

All Listed Sponsors
collaborator

Small and Medium Business Administration

UNKNOWN

lead

Yonsei University

OTHER

NCT01976494 - The Efficacy and Safety of Accufuser Omnibus® (Elastomeric Infusion Pump); Comparative Clinical Trial | Biotech Hunter | Biotech Hunter