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

NCT03102333 | Completed DMC

• 1 other identifier: CAUH-SP1
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Demanded numbers of bolus button

  Change from immediately to 24 hours after operation

Secondary Outcomes (1)

• Pain intensity

  Change from immediately to 24 hours after operation

Study Arms (2)

Constant-rate Infusion

ACTIVE COMPARATOR

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

Variable-rate Feedback Infusion

ACTIVE COMPARATOR

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

Interventions

Variable-rate Feedback Infusion mode 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

Variable-rate Feedback Infusion

Constant-rate Infusion mode 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

Constant-rate Infusion

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spine fusion surgery at Chung-Ang University Hospital with IV- PCA under general anesthesia

You may not qualify if:

• Unrecorded type of anesthetic agent
• Denial to the study
• Brain disorder
• Cardiopulmonary disease
• Psychiatric disorders

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, 156-755, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: April 5, 2017
• Study Start: December 30, 2016
• Primary Completion: December 29, 2017
• Study Completion: December 29, 2017
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

KR (1)