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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02402621
Enrollment
111
Registered
2015-03-30
Start date
2015-04-30
Completion date
2015-09-30
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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

Interventions

DRUGfentanyl

fentanyl with antiemetic drug

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 69 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Amount and number of postoperative analgesic requirementsParticipants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary

MeasureTime frame
Number of participants with complicationsUp to 48 hours
Visual Analog Scale (VAS)Up to 48 hours
Postoperative nausea and vomitingUp to 48 hours
Respiratory rate, oxygen saturationUp to 48 hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026