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

November 30, 2015 updated by: Young-Kug Kim, Asan Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional analgesic group
fentanyl
Drug: fentanyl
fentanyl with antiemetic drug
Experimental: Model based analgesic group
fentanyl
Drug: fentanyl
fentanyl with antiemetic drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Young-Kug Kim, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0267

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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