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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Complete Spinal Cord Injury Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No