Back to resultsThe Effects of Epidural Anesthesia on the Bioavailability of Nitric Oxide and Renal Function in Patients Undergoing Laparoscopic Surgery
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Epidural anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- ASA class 1 or 2 adult patients scheduled for endoscopic prostatectomy
Exclusion Criteria:
- Patient refusal
- Patients on diuretics
- Patients with renal failure (eGFR < 60 ml/min/1.73 m2)
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
G group
G+E group
Arm Description
G group = General anesthesia group
G+E group = General anesthesia + epidural anesthesia group
Outcomes
Primary Outcome Measures
blood pressure with heart rate variability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01325844
Brief Title
The Effects of Epidural Anesthesia on the Bioavailability of Nitric Oxide and Renal Function in Patients Undergoing Laparoscopic Surgery
Official Title
The Effects of Epidural Anesthesia on the Bioavailability of Nitric Oxide and Renal Function in Patients Undergoing Laparoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was designed to investigate the effects of epidural anesthesia combined with general anesthesia during laparoscopic surgery. The investigators hypothesized that epidural anesthesia will effectively block the activation of the sympathetic nervous system during surgery, thus activating nitric oxide and reducing splanchnic ischemia and decrease in postoperative renal function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G group
Arm Type
No Intervention
Arm Description
G group = General anesthesia group
Arm Title
G+E group
Arm Type
Experimental
Arm Description
G+E group = General anesthesia + epidural anesthesia group
Intervention Type
Procedure
Intervention Name(s)
Epidural anesthesia
Intervention Description
0.5% ropivacaine infusion via epidural catheter at 5ml/hr during general anesthesia
Primary Outcome Measure Information:
Title
blood pressure with heart rate variability
Time Frame
10 minutes after anesthesia induction
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA class 1 or 2 adult patients scheduled for endoscopic prostatectomy
Exclusion Criteria:
Patient refusal
Patients on diuretics
Patients with renal failure (eGFR < 60 ml/min/1.73 m2)
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effects of Epidural Anesthesia on the Bioavailability of Nitric Oxide and Renal Function in Patients Undergoing Laparoscopic Surgery
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