Complete Spinal Cord InjuryNCT01683916
Anesthetic Requirement and Stress Hormone Response During Surgery in Spinal Cord-injured Patients
An observational study of Complete Spinal Cord Injury and Surgery, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Complete Spinal Cord Injury, Surgery
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Cardiovascular, pulmonary, or metabolic diseases. Patients who took medications that would influence autonomic or cardiovascular responses to the surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine
Gwangju, 501-757
About this study
Official title: 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.
Read the 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.
- Conditions
- Complete Spinal Cord Injury, Surgery
- Keywords
- spinal cord injury, stress hormone, surgery, bispectral index value, volatile anesthetic
- Medical subject headings
- Spinal Cord Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung Yeon Yoo, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683916
- Sponsor's protocol ID
- 2010-12-198
- Status last verified
- Dec 2010
- First submitted
- 8 Sep 2012
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chonnam National University Hospital IRB
- ClinicalTrials.gov ID
- NCT01683916
- Acronym / sponsor ID
- 2010-12-198
- Conditions
- Complete Spinal Cord Injury, Surgery
- Keywords
- spinal cord injury, stress hormone, surgery, bispectral index value, volatile anesthetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Cardiovascular, pulmonary, or metabolic diseases. Patients who took medications that would influence autonomic or cardiovascular responses to the surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complete Spinal Cord Injury and Surgery, run by Chonnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.