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:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01325844
First received: March 28, 2011
Last updated: February 2, 2012
Last verified: February 2012
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01325844

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

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01325844     History of Changes
Other Study ID Numbers: 4-2010-0537
Study First Received: March 28, 2011
Last Updated: February 2, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Anesthetics
Nitric Oxide
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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
Cardiovascular Agents
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014