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

NCT ID: NCT03102333

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-30
• Study Completion Date: 2017-12-29

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Constant-rate Infusion mode

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

Variable-rate Feedback Infusion mode

Intervention Type: DEVICE

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

Interventions

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 Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Chongwha Baek

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chung-Ang University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CAUH-SP1

Identifier Type: -

Identifier Source: org_study_id