Comparison Between Conventional and Model-based Infusion Strategy of IV PCA in Patients Undergoing RALP

Study Overview
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Brief Summary
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Comparing postoperative analgesics requirements and complications between conventional and model-based infusion strategy of intravenous patient-controlled analgesia in patients who undergoing robot assisted laparoscopic radical prostatectomy Group A: conventional intravenous patient-controlled analgesia, Group B: model-based infusion strategy of intravenous patient-controlled analgesia

Detailed Description
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The investigators compared postoperative analgesics requirements and complications between conventional and model-based infusion strategy of intravenous patient-controlled analgesia (IV PCA) in patients who undergoing robot assisted laparoscopic radical prostatectomy (RALP) Group A: conventional IV PCA, Group B: model based IV PCA Primary endpoint: comparison of postoperative analgesic requirements in patient undergoing robot assisted laparoscopic radical prostatectomy (RALP) between conventional patient controlled analgesia (PCA) (Group A) and effective-compartment based dosing strategy of PCA (Group B) Secondary endpoint: 1) VAS analysis between two groups, 2) postoperative nausea and vomiting analysis between two groups, 3) complication evaluation between two groups

Official Title
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Comparison Between Conventional and Model-based Infusion Strategy of Intravenous Patient-controlled Analgesia in Patients Undergoing Robot Assisted Laparoscopic Radical Prostatectomy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who is scheduled to get a robot assisted laparoscopic radical prostatectomy Patient who agree to get a patient controlled analgesia Exclusion Criteria: American Society of Anesthesiologist (ASA) physical status over III History of alcohol or drug addiction History of acute or chronic pain or pain treatment Allergic to opioid analgesics BMI over 30 kg/m2 History of sleep apnea or respiratory complications

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional analgesic group<br>fentanyl | Drug: fentanyl<br>* fentanyl with antiemetic drug<br>|
| Experimental: Model based analgesic group<br>fentanyl | Drug: fentanyl<br>* fentanyl with antiemetic drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount and number of postoperative analgesic requirements |  | Participants will be followed for the duration of hospital stay, an expected average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with complications |  | Up to 48 hours | 
| Visual Analog Scale (VAS) |  | Up to 48 hours | 
| Postoperative nausea and vomiting |  | Up to 48 hours | 
| Respiratory rate, oxygen saturation |  | Up to 48 hours |