Comparison: Constant-rate Infusion Plus Demanding Dosing VS Variable-rate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 78
- Locations
- 2
- Primary Endpoint
- Demanded numbers of bolus button
Study Overview
Brief Summary
In the case of the newlys developed PCA, the infusion rate is increased according to the patient's need for bolus button, so that the pain can be controlled more efficiently.
Detailed Description
In the case of the existing iv-pca, the analgesic drug was injected into the patient at a constant rate (ex. 1 ml / hr) and additional pain was controlled through the bolus dose (1 ml).
As a result, the analgesic effect was insufficient, or the effect was excessive, causing side effects (nausea, vomiting, sedation, dizziness). Especially In spinal surgery, the degree of pain sharply decreases from day 1 to day 2. Classic iv-pca with constant infusion rate can not reflect this result. But in the case of the newlys developed PCA, the infusion rate is increased according to the patient's need for bolus button, so that the pain can be controlled more efficiently. If the bolus button is not pressed for a certain period of time, it is expected that the injection rate will be reduced and the side effect caused by the analgesic agent will be decreased.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Spine fusion surgery at Chung-Ang University Hospital with IV- PCA under general anesthesia
Exclusion Criteria
- •Unrecorded type of anesthetic agent
- •Denial to the study
- •Brain disorder
- •Cardiopulmonary disease
- •Psychiatric disorders
Arms & Interventions
Constant-rate Infusion
INTERVENTION : Constant-rate Infusion mode : The PCA regimen consisted of fentanyl 20 μg/kg and Ramosetron Hcl 0.3 mg (total volume including saline: 100 ml) and was programmed to deliver 1 ml /h as a background infusion and a bolus of 1.5 ml on-demand, with a 15 min lockout time during a 48 h period
Intervention: Constant-rate Infusion mode (Device)
Variable-rate Feedback Infusion
INTERVENTION : Variable-rate Feedback Infusion mode :The PCA regimen consisted of fentanyl 20 μg/kg and Ramosetron Hcl 0.3 mg (total volume including saline: 100 ml) and was programmed to deliver 1 ml /h as a background infusion and a bolus of 1.5 ml on-demand, with a 15 min lockout time. It can increment or decrement rate(0.2ml/hr) by press bolus button during a 48 h period
Intervention: Variable-rate Feedback Infusion mode (Device)
Outcomes
Primary Outcomes
Demanded numbers of bolus button
Time Frame: Change from immediately to 24 hours after operation
Secondary Outcomes
- Pain intensity(Change from immediately to 24 hours after operation)
Investigators
Chongwha Baek
Professor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine