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Completed

NCT Number: NCT02402621

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

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

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Key information

Age range

20 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Fentanyl

Drug

fentanyl with antiemetic drug

Primary outcomes

  1. Amount and number of postoperative analgesic requirements

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary outcomes

  1. Number of participants with complications

    Time frame: Up to 48 hours

  2. Visual Analog Scale (VAS)

    Time frame: Up to 48 hours

  3. Postoperative nausea and vomiting

    Time frame: Up to 48 hours

  4. Respiratory rate, oxygen saturation

    Time frame: Up to 48 hours

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 30, 2015
Registry last updated
Dec 2, 2015

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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