Back to resultsEffect of Adding Sufentanil to Epidural Ropivacaine on Perioperative Metabolic and Stress Responses in Combined General/Epidural Anaesthesia for Geriatric Radical Retropubic Prostatectomy
Primary Purpose
Prostatic Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
epidural infusion of saline, ropivecaine, or ropivacaine and sufentanil
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostatic Cancer focused on measuring patients of prostatic cancer aged more than 65 years
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- contraindication to epidural catheterization
Sites / Locations
- Severance Hospital
Outcomes
Primary Outcome Measures
plasma glucose, insulin, cortisol, epinephrine, norepinephrine, prolactin
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01086956
Brief Title
Effect of Adding Sufentanil to Epidural Ropivacaine on Perioperative Metabolic and Stress Responses in Combined General/Epidural Anaesthesia for Geriatric Radical Retropubic Prostatectomy
Official Title
Effect of Adding Sufentanil to Epidural Ropivacaine on Perioperative Metabolic and Stress Responses in Combined General/Epidural Anaesthesia for Geriatric Radical Retropubic Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare metabolic and stress responses in combined general/epidural anesthesia in geriatric cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Cancer
Keywords
patients of prostatic cancer aged more than 65 years
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
epidural infusion of saline, ropivecaine, or ropivacaine and sufentanil
Primary Outcome Measure Information:
Title
plasma glucose, insulin, cortisol, epinephrine, norepinephrine, prolactin
Time Frame
from preoperative baseline to postoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
contraindication to epidural catheterization
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
21108620
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Adding Sufentanil to Epidural Ropivacaine on Perioperative Metabolic and Stress Responses in Combined General/Epidural Anaesthesia for Geriatric Radical Retropubic Prostatectomy
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