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

NCT ID: NCT02402621

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional analgesic group

fentanyl

Group Type ACTIVE_COMPARATOR

fentanyl

Intervention Type DRUG

fentanyl with antiemetic drug

Model based analgesic group

fentanyl

Group Type EXPERIMENTAL

fentanyl

Intervention Type DRUG

fentanyl with antiemetic drug

Interventions

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fentanyl

fentanyl with antiemetic drug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

69 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young-Kug Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Kug Kim

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2015-0267

Identifier Type: -

Identifier Source: org_study_id