- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01325844
The Effects of Epidural Anesthesia on the Bioavailability of Nitric Oxide and Renal Function in Patients Undergoing Laparoscopic Surgery
February 2, 2012 updated by: Yonsei University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 120-752
- Severance Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: G group
G group = General anesthesia group
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Experimental: G+E group
G+E group = General anesthesia + epidural anesthesia group
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0.5% ropivacaine infusion via epidural catheter at 5ml/hr during general anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood pressure with heart rate variability
Time Frame: 10 minutes after anesthesia induction
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10 minutes after anesthesia induction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
March 28, 2011
First Submitted That Met QC Criteria
March 29, 2011
First Posted (Estimate)
March 30, 2011
Study Record Updates
Last Update Posted (Estimate)
February 6, 2012
Last Update Submitted That Met QC Criteria
February 2, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2010-0537
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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