NCT02402621

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

5 months

First QC Date

March 23, 2015

Last Update Submit

November 30, 2015

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Amount and number of postoperative analgesic requirements

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

Secondary Outcomes (4)

  • Number of participants with complications

    Up to 48 hours

  • Visual Analog Scale (VAS)

    Up to 48 hours

  • Postoperative nausea and vomiting

    Up to 48 hours

  • Respiratory rate, oxygen saturation

    Up to 48 hours

Study Arms (2)

Conventional analgesic group

ACTIVE COMPARATOR

fentanyl

Drug: fentanyl

Model based analgesic group

EXPERIMENTAL

fentanyl

Drug: fentanyl

Interventions

fentanylDRUG

fentanyl with antiemetic drug

Conventional analgesic groupModel based analgesic group

Eligibility Criteria

Age20 Years - 69 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who is scheduled to get a robot assisted laparoscopic radical prostatectomy
  • Patient who agree to get a patient controlled analgesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Young-Kug Kim

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 30, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

KR(1)