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

Asan Medical Center

Status: Completed

Conditions: Prostate Cancer

Treatments: Drug: fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT02402621

2015-0267

Details and patient eligibility

About

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

Full 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

Enrollment: 111 patients

Sex: Male

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 2 patient groups

Conventional analgesic group

Active Comparator group

Description:

fentanyl

Treatment:

Drug: fentanyl

Model based analgesic group

Experimental group

Description:

fentanyl

Treatment:

Drug: fentanyl