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The Effects of Epidural Anesthesia on the Bioavailability of Nitric Oxide and Renal Function in Patients Undergoing Laparoscopic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01325844
First Posted: March 30, 2011
Last Update Posted: February 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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.

Condition Intervention
Prostate Cancer Procedure: Epidural anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Epidural Anesthesia on the Bioavailability of Nitric Oxide and Renal Function in Patients Undergoing Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • blood pressure with heart rate variability [ Time Frame: 10 minutes after anesthesia induction ]

Enrollment: 45
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: G group
G group = General anesthesia group
Experimental: G+E group
G+E group = General anesthesia + epidural anesthesia group
Procedure: Epidural anesthesia
0.5% ropivacaine infusion via epidural catheter at 5ml/hr during general anesthesia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325844


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01325844     History of Changes
Other Study ID Numbers: 4-2010-0537
First Submitted: March 28, 2011
First Posted: March 30, 2011
Last Update Posted: February 6, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Anesthetics
Nitric Oxide
Central Nervous System Depressants
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents