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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

fentanyl

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional analgesic group

Model based analgesic group

Arm Description

fentanyl

Outcomes

Primary Outcome Measures

Amount and number of postoperative analgesic requirements

Secondary Outcome Measures

Number of participants with complications

Visual Analog Scale (VAS)

Postoperative nausea and vomiting

Respiratory rate, oxygen saturation

Full Information

NCT ID

NCT02402621

First Posted

March 23, 2015

Last Updated

November 30, 2015

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02402621

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

111 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional analgesic group

Arm Type

Active Comparator

Arm Description

fentanyl

Arm Title

Model based analgesic group

Arm Type

Experimental

Arm Description

fentanyl

Intervention Type

Drug

Intervention Name(s)

fentanyl

Intervention Description

fentanyl with antiemetic drug

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Number of participants with complications

Time Frame

Up to 48 hours

Title

Visual Analog Scale (VAS)

Time Frame

Up to 48 hours

Title

Postoperative nausea and vomiting

Time Frame

Up to 48 hours

Title

Respiratory rate, oxygen saturation

Time Frame

Up to 48 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Young-Kug Kim

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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