NCT01086956

Brief Summary

The purpose of this study is to compare metabolic and stress responses in combined general/epidural anesthesia in geriatric cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

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

Study Start

First participant enrolled

September 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2010

Completed
Last Updated

November 11, 2010

Status Verified

November 1, 2010

Enrollment Period

1.2 years

First QC Date

March 12, 2010

Last Update Submit

November 10, 2010

Conditions

Prostatic Cancer

Keywords

patients of prostatic cancer aged more than 65 years

Outcome Measures

Primary Outcomes (1)

  • plasma glucose, insulin, cortisol, epinephrine, norepinephrine, prolactin

    from preoperative baseline to postoperative 24 hours

Interventions

epidural infusion of saline, ropivecaine, or ropivacaine and sufentanilDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • elective RRP for prostatic cancer scheduled in the morning (9-11 a.m.)
  • patients aged more than 65 years
  • ASA physical status I or II
  • absence of contraindications to epidural approach
  • absence of a history of chronic pain or opioid medication

You may not qualify if:

  • contraindication to epidural catheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Hong JY, Yang SC, Yi J, Kil HK. Epidural ropivacaine and sufentanil and the perioperative stress response after a radical retropubic prostatectomy. Acta Anaesthesiol Scand. 2011 Mar;55(3):282-9. doi: 10.1111/j.1399-6576.2010.02360.x. Epub 2010 Nov 25.

    PMID: 21108620DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

RopivacaineSufentanil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 15, 2010

Study Start

September 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 11, 2010

Record last verified: 2010-11

Locations

KR(1)