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

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ClinicalTrials.gov Identifier: NCT03102333
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Chongwha Baek, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 30, 2016
Actual Primary Completion Date : December 29, 2017
Actual Study Completion Date : December 29, 2017

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




Primary Outcome Measures :
  1. Demanded numbers of bolus button [ Time Frame: Change from immediately to 24 hours after operation ]

Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: Change from immediately to 24 hours after operation ]
    by Numerical Rating Scale(NRS)



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102333


Locations
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Korea, Republic of
Chung-Ang University Hospital
Seoul, Korea, Republic of, 156-755
Sponsors and Collaborators
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
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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: April 5, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations