Anesthetic Requirement and Stress Hormone Response During Surgery in Spinal Cord-injured Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Chonnam National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kyung Yeon Yoo, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01683916
First received: September 8, 2012
Last updated: September 11, 2012
Last verified: December 2010
  Purpose

Spinal cord injury (SCI) reduces anesthetic requirements and stress hormonal responses. Anesthetic requirements and stress hormone response are compared in SCI patients undergoing anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or remifentanil.


Condition
Complete Spinal Cord Injury
Surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Chonnam National University Hospital IRB

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Estimated Enrollment: 45
Study Start Date: January 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Nitrous oxide (N2O) is often used for anesthetic adjuvant, but may be associated with side effects and toxicities. Remifentanil shares characteristics with N2O, including anesthetic-reducing and antinociceptive effects and a rapid recovery. Anesthetic requirements and stress hormone response in SCI patients undergoing anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or remifentanil. Forty-five SCI patients scheduled to undergo pressor sore surgery below the level of the injury are randomly allocated to receive either sevoflurane alone (control, n=15), or combined with 67% N2O (n=15) or target-controlled infusions of 1.37 ng/mL remifentanil (n=15). Sevoflurane concentration is titrated to maintain a Bispectral Index (BIS) value of 40-50. Measurements include end-tidal sevoflurane concentrations, mean arterial blood pressure (MAP), heart rate (HR), and plasma catecholamine and cortisol concentrations.

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ASA physical status II, with chronic, clinically complete cord injuries scheduled for a surgery for pressure sore below the level of the neurologic lesion under general anesthesia.

Criteria

Inclusion Criteria:

  • ASA physical status II, with chronic, clinically complete cord injuries scheduled for a surgery for pressure sore below the level of the neurologic lesion under general anesthesia.

Exclusion Criteria:

  • Cardiovascular, pulmonary, or metabolic diseases. Patients who took medications that would influence autonomic or cardiovascular responses to the surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683916

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine Recruiting
Gwangju, Korea, Republic of, 501-757
Contact: Young W Won    82-62-220-6893 ext 6895    ywwon@jnu.ac.kr   
Principal Investigator: Kyung Y Yoo, M.D., Ph.D.         
Sponsors and Collaborators
Chonnam National University Hospital
  More Information

No publications provided

Responsible Party: Kyung Yeon Yoo, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01683916     History of Changes
Other Study ID Numbers: 2010-12-198
Study First Received: September 8, 2012
Last Updated: September 11, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chonnam National University Hospital:
spinal cord injury
stress hormone
surgery
bispectral index value
volatile anesthetic

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014