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

September 8, 2012
September 11, 2012
January 2011
December 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01683916 on ClinicalTrials.gov Archive Site
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Anesthetic Requirement and Stress Hormone Response During Surgery in Spinal Cord-injured Patients
Chonnam National University Hospital IRB

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Complete Spinal Cord Injury
  • Surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
June 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
10 Years to 70 Years
No
Korea, Republic of
 
NCT01683916
2010-12-198
No
Kyung Yeon Yoo, Chonnam National University Hospital
Chonnam National University Hospital
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Chonnam National University Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP