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Completed

NCT Number: NCT03102333

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

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.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung-Ang University Hospital

Seoul, 156-755, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Demanded numbers of bolus button

    Time frame: Change from immediately to 24 hours after operation

Secondary outcomes

  1. Pain intensity

    Time frame: Change from immediately to 24 hours after operation

    by Numerical Rating Scale(NRS)

Sponsors and collaborators

Lead sponsor

Chung-Ang University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2017
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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