Comparison: Constant-rate Infusion Plus Demanding Dosing VS Variable-rate Feedback Infusion Plus Demanding Dosing

Pain, Postoperative Clinical Trial

Official title:

Comparison: Constant-rate Infusion Plus Demanding Dosing VS Variable-rate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102333
• Other study ID #: CAUH-SP1
• Status: Completed
• Phase: N/A
• Start date: December 30, 2016
• Est. completion date: December 29, 2017

Study information

• Verified date: July 2018
• Source: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 29, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demanded numbers of bolus button		Change from immediately to 24 hours after operation
Secondary	Pain intensity	by Numerical Rating Scale(NRS)	Change from immediately to 24 hours after operation