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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402621
• Other study ID #: 2015-0267
• Status: Completed
• Phase: N/A
• First received: March 23, 2015
• Last updated: November 30, 2015
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Drug:
• fentanyl
fentanyl with antiemetic drug

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount and number of postoperative analgesic requirements		Participants will be followed for the duration of hospital stay, an expected average of 1 week	No
Secondary	Number of participants with complications		Up to 48 hours	Yes
Secondary	Visual Analog Scale (VAS)		Up to 48 hours	No
Secondary	Postoperative nausea and vomiting		Up to 48 hours	Yes
Secondary	Respiratory rate, oxygen saturation		Up to 48 hours	Yes