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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: fentanyl

• Registration Number: NCT02402621
• Lead Sponsor: Asan Medical Center

Brief Summary

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

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

1. 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)

2. Secondary endpoint: 1) VAS analysis between two groups, 2) postoperative nausea and vomiting analysis between two groups, 3) complication evaluation between two groups

Study Timeline

• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-30
• Study Start: 2015-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional analgesic group	fentanyl	fentanyl
Model based analgesic group	fentanyl	fentanyl

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of participants with complications	Up to 48 hours
Respiratory rate, oxygen saturation	Up to 48 hours
Visual Analog Scale (VAS)	Up to 48 hours
Postoperative nausea and vomiting	Up to 48 hours

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of