Anesthetic Requirement and Stress Hormone Response During Surgery in Spinal Cord-injured Patients
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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 |
| 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) |
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 |
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.
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| 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. | |
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 Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013