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

Sponsor

Chung-Ang University Hosptial, Chung-Ang University College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03102333

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Device: Variable-rate Feedback Infusion mode Device: Constant-rate Infusion mode	N/A

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

Actual Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 30, 2016

Actual Primary Completion Date :

Dec 29, 2017

Actual Study Completion Date :

Dec 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Device: 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
Active Comparator: 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	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

Arm

Intervention/Treatment

Active Comparator: 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

Device: 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

Active Comparator: 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

Device: Variable-rate Feedback Infusion mode

Outcome Measures

Primary Outcome Measures

Demanded numbers of bolus button [Change from immediately to 24 hours after operation]

Secondary Outcome Measures

Pain intensity [Change from immediately to 24 hours after operation]
by Numerical Rating Scale(NRS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chung-Ang University Hospital	Seoul		Korea, Republic of	156-755

Sponsors and Collaborators

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chongwha Baek, Professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

ClinicalTrials.gov Identifier:

NCT03102333

Other Study ID Numbers:

CAUH-SP1

First Posted:

Apr 5, 2017

Last Update Posted:

Jul 18, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jul 18, 2018