Elderly Patients Undergoing Spinal SurgeryNCT01839227
Post-operative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery
A study testing Neurologic and neuropsychologic tests in people with Elderly Patients Undergoing Spinal Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Post operative cognitive dysfunction (POCD) is a well-recognized complication of patients undergoing cardiac surgery. Previous studies reported near-infrared spectroscopy provides information on the occurrence of cerebral desaturation resulted in POCD. But evidence of POCD after general surgery has been lacking. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Elderly Patients Undergoing Spinal Surgery
- What is being tested?
- Neurologic and neuropsychologic tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Jul 2014
- Phase
- Interventional
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- the patient undergoing the lumbar spine surgery in severance hospital
Who cannot join
- Patients who had previous cerebral disease, dementia, severe problems in hearing and understanding, or who were unable to provide informed consent were excluded.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
Post operative cognitive dysfunction (POCD) is a well-recognized complication of patients undergoing cardiac surgery. Previous studies reported near-infrared spectroscopy provides information on the occurrence of cerebral desaturation resulted in POCD. But evidence of POCD after general surgery has been lacking. Especially, the prone position is used primarily for surgical access to the posterior spine, if there is any significant lowering of the legs or tilt of the entire table, venous returns may be decrease or augmented accordingly. The purpose of this study was to examine the relationship between POCD and intra-operative cerebral oxygen saturation after spine surgery in elderly patients.
- Being tested
- Neurologic and neuropsychologic tests
- Keywords
- Post-operative cognitive dysfunction, regional cerebral oxygen saturation, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurologic and neuropsychologic testsOther
Cognitive functioning was assessed with the following test: Korean Mini-Mental State Examination (K-MMSE) and visuomotor test of D-LOTCA battery.
Regional cerebral oxygen saturation was continuously monitored using the INVOS 5100 (somatics,Troy, MI) with bifrontal placement of two sensors before the induction of the anesthesia until the end of operation.
Baseline rSO2 was defined as the average saturation value over a 1 min period before induction of general anesthesia, beginning approximately 3 min after the sensors were applied in supine position. After the induction, baseline prone rSO2 was defined over a 5min period after the change of position.
There is no intervention were made according to rSO2 values. Physiologic variables including BIS, PaCO2,PaO2, glucose, electrolyte, hematocrit, HR, MAP, and nasopharyngeal temperature were measured every 1 hours during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| regional cerebral oxygen saturation | Experimental | Not described Receives: Other: Neurologic and neuropsychologic tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
K-MMSE
- preoperative neuropsychological evaluation (the day before the surgery)
- intraoperative rSO2 data monitoring
3-1. immediate postoperative neuropsychological evaluation (postoperative 4th~7th day)
3-2. remote postoperative neuropsychological evaluation (postoperative 1month)
- Intraoperative
Measured: change of K-MMSE from baseine to 1 month
Secondary outcomes (2)
visuomotor test(D-LOTCA battery)
:Visuomotor test (D-LOTCA battery)
- Copy Geometric Forms
- Two Dimensional Model
- Pegboard Construction
- Block Design(colored)
- Reproduction of Puzzle
- Drawing Clock
Measured: measuring for visuomotor test during baseline and 1 month
Regional cerebral oxymetry monitoring
- Correlation between rSO2 and POCD
- The average, left and right absolute rSO2 values were collected every 30 seconds. rSO2 value was recorded as excel data.
- Absolute rSO2 value and AUT(area under the threshold) send beneath the absolute threshold limits of 40%, 50%, 60% and 20% under the baseline. AUT was calculated based on this formula: AUT (present)=AUT (past)+(rSO2 threshold-rSO2 value)×sample rate
- cutoff value of rSO2 predictive POCD
- Correlation of physical value affecting rSO2 and POCD (BIS, PaCO2,PaO2, glucose, electrolyte, hematocrit, HR, MAP, and nasopharyngeal temperature, intraoperative blood loss, amount of intake fluid, total dose of vasopressor)
Measured: measuring for Regional cerebral oxymetry monitoring during baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startNov 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Elderly Patients Undergoing Spinal SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839227
- Sponsor's protocol ID
- 1-2012-0039
- Status last verified
- Jan 2015
- First submitted
- 16 Apr 2013
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Annau Z. The effect of carbonic anhydrase inhibition on electrical self stimulation of the brain during hypoxia. Life Sci. 1977 Mar 15;20(6):1043-9. doi: 10.1016/0024-3205(77)90292-2. No abstract available.
PubMed 15172Cox PJ, Farmer PB, Jarman M, Kinas RW, Stec WJ. Stereoselectivity in the metabolism of the enantiomers of cyclophosphamide in mice, rats, and rabbits. Drug Metab Dispos. 1978 Nov-Dec;6(6):617-22. No abstract available.
PubMed 33022Stolke D, Seifert V. [Early or late operation on the ruptured aneurysm? An analysis based on 356 cases]. Neurochirurgia (Stuttg). 1988 May;31(3):81-7. doi: 10.1055/s-2008-1053907. German.
PubMed 3405354Al'tshuler NS. [Problems of tuberculosis control in the activities of the progressive medical community in prerevolutionary Russia]. Probl Tuberk. 1979 Dec;(12):62-5. No abstract available. Russian.
PubMed 392499Besch PK, Bermes EW Jr, McDonald HJ. Report of the second conference on education in clinical chemistry. Clin Chem. 1976 Apr;22(4):541-9. No abstract available.
PubMed 3299Tremblay NA, Davies DW, Volgyesi G, Kadar K, Steward DJ. Sodium nitroprusside: factors which attenuate its action. Studies with the isolated gracilis muscle of the dog. Can Anaesth Soc J. 1977 Nov;24(6):641-50. doi: 10.1007/BF03006708.
PubMed 22395Neutral all-purpose cleaner. Exec Housekeep Today. 1990 Nov;11(11):26. No abstract available.
PubMed 10107940Avolio G, Cacciabue M, Rolla G, Caria E, Oliaro A, Carlino F, Pepino E, Polizzi S, Bucca C. [Functional compromise of the small airways in subjects exposed to SiO2]. Minerva Med. 1986 Nov 30;77(45-46):2183-5. Italian.
PubMed 3025780Eulert J. [Transplantation of epiphyseal cartilage: experimental study]. Rev Chir Orthop Reparatrice Appar Mot. 1977;63 Suppl 2:136-7. No abstract available. French.
PubMed 143022Razin SV, Kekelidze MG, Lukanidin EM. [Spatial organization of replicons in the eukaryotic nucleus: attachment of replication initiation regions to the nuclear skeleton]. Mol Biol (Mosk). 1986 Mar-Apr;20(2):387-95. Russian.
PubMed 3010082Varki AP, Armitage JO, Feagler JR. Typhlitis in acute leukemia: successful treatment by early surgical intervention. Cancer. 1979 Feb;43(2):695-7. doi: 10.1002/1097-0142(197902)43:23.0.co;2-9.
PubMed 283878[Exosurf-Neonatal: the synthetic surfactant. Introductory symposium, 20 June 1992]. Monatsschr Kinderheilkd. 1992 Sep;140(9 [EXOSURF]):1-12. No abstract available. German.
PubMed 1406736Should I consider using an insulin pump to take insulin for type 2 diabetes? Johns Hopkins Med Lett Health After 50. 2004 Aug;17(6):8. No abstract available.
PubMed 15281175Kopacz DJ, Allen HW. Accidental intravenous levobupivacaine. Anesth Analg. 1999 Oct;89(4):1027-9. doi: 10.1097/00000539-199910000-00038. No abstract available.
PubMed 10512284Rossini F, Terruzzi E, Perego D, Miccolis I, Rivolta F, Manca E, Pogliani EM. Long-term follow-up of patients with intermediate or high-grade non-Hodgkin lymphoma treated with a combination of cyclophosphamide, epirubicin, vincristine, and prednisone. Cancer. 2004 Jan 15;100(2):350-5. doi: 10.1002/cncr.11907.
PubMed 14716771
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery
- ClinicalTrials.gov ID
- NCT01839227
- Acronym / sponsor ID
- 1-2012-0039
- Keywords
- Post-operative cognitive dysfunction, regional cerebral oxygen saturation, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Apr 2013 (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.
Post operative cognitive dysfunction (POCD) is a well-recognized complication of patients undergoing cardiac surgery. Previous studies reported near-infrared spectroscopy provides information on the occurrence of cerebral desaturation resulted in POCD. But evidence of POCD after general surgery has been lacking. Especially, the prone position is used primarily for surgical access to the posterior spine, if there is any significant lowering of the legs or tilt of the entire table, venous returns may be decrease or augmented accordingly. The purpose of this study was to examine the relationship between POCD and intra-operative cerebral oxygen saturation after spine surgery in elderly patients.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| regional cerebral oxygen saturation | Experimental | Other: Neurologic and neuropsychologic tests |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- the patient undergoing the lumbar spine surgery in severance hospital
Key exclusion criteria (1 listed)
- Patients who had previous cerebral disease, dementia, severe problems in hearing and understanding, or who were unable to provide informed consent were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurologic and neuropsychologic testsCognitive functioning was assessed with the following test: Korean Mini-Mental State Examination (K-MMSE) and visuomotor test of D-LOTCA battery. Regional cerebral oxygen saturation was continuously monitored using the INVOS 5100 (somatics,Troy, MI) with bifrontal placement of two sensors before the induction of the anesthesia until the end of operation. Baseline rSO2 was defined as the average saturation value over a 1 min period before induction of general anesthesia, beginning approximately 3 min after the sensors were applied in supine position. After the induction, baseline prone rSO2 was defined over a 5min period after the change of position. There is no intervention were made according to rSO2 values. Physiologic variables including BIS, PaCO2,PaO2, glucose, electrolyte, hematocrit, HR, MAP, and nasopharyngeal temperature were measured every 1 hours during the surgery. | Other | regional cerebral oxygen saturation |
Primary outcome
K-MMSE
Time frame: change of K-MMSE from baseine to 1 month
1. preoperative neuropsychological evaluation (the day before the surgery) 2. intraoperative rSO2 data monitoring 3-1. immediate postoperative neuropsychological evaluation (postoperative 4th~7th day) 3-2. remote postoperative neuropsychological evaluation (postoperative 1month) 4. Intraoperative
2 secondary outcomes
visuomotor test(D-LOTCA battery)
Time frame: measuring for visuomotor test during baseline and 1 month
Regional cerebral oxymetry monitoring
Time frame: measuring for Regional cerebral oxymetry monitoring during baseline and 1 month
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 28 Jan 2015.
- Background: PubMed 15172Annau Z. The effect of carbonic anhydrase inhibition on electrical self stimulation of the brain during hypoxia. Life Sci. 1977 Mar 15;20(6):1043-9. doi: 10.1016/0024-3205(77)90292-2. No abstract available.
- Background: PubMed 33022Cox PJ, Farmer PB, Jarman M, Kinas RW, Stec WJ. Stereoselectivity in the metabolism of the enantiomers of cyclophosphamide in mice, rats, and rabbits. Drug Metab Dispos. 1978 Nov-Dec;6(6):617-22. No abstract available.
- Background: PubMed 3405354Stolke D, Seifert V. [Early or late operation on the ruptured aneurysm? An analysis based on 356 cases]. Neurochirurgia (Stuttg). 1988 May;31(3):81-7. doi: 10.1055/s-2008-1053907. German.
- Background: PubMed 392499Al'tshuler NS. [Problems of tuberculosis control in the activities of the progressive medical community in prerevolutionary Russia]. Probl Tuberk. 1979 Dec;(12):62-5. No abstract available. Russian.
- Background: PubMed 3299Besch PK, Bermes EW Jr, McDonald HJ. Report of the second conference on education in clinical chemistry. Clin Chem. 1976 Apr;22(4):541-9. No abstract available.
- Background: PubMed 22395Tremblay NA, Davies DW, Volgyesi G, Kadar K, Steward DJ. Sodium nitroprusside: factors which attenuate its action. Studies with the isolated gracilis muscle of the dog. Can Anaesth Soc J. 1977 Nov;24(6):641-50. doi: 10.1007/BF03006708.
- Background: PubMed 10107940Neutral all-purpose cleaner. Exec Housekeep Today. 1990 Nov;11(11):26. No abstract available.
- Background: PubMed 3025780Avolio G, Cacciabue M, Rolla G, Caria E, Oliaro A, Carlino F, Pepino E, Polizzi S, Bucca C. [Functional compromise of the small airways in subjects exposed to SiO2]. Minerva Med. 1986 Nov 30;77(45-46):2183-5. Italian.
- Background: PubMed 143022Eulert J. [Transplantation of epiphyseal cartilage: experimental study]. Rev Chir Orthop Reparatrice Appar Mot. 1977;63 Suppl 2:136-7. No abstract available. French.
- Background: PubMed 3010082Razin SV, Kekelidze MG, Lukanidin EM. [Spatial organization of replicons in the eukaryotic nucleus: attachment of replication initiation regions to the nuclear skeleton]. Mol Biol (Mosk). 1986 Mar-Apr;20(2):387-95. Russian.
- Background: PubMed 283878Varki AP, Armitage JO, Feagler JR. Typhlitis in acute leukemia: successful treatment by early surgical intervention. Cancer. 1979 Feb;43(2):695-7. doi: 10.1002/1097-0142(197902)43:23.0.co;2-9.
- Background: PubMed 1406736[Exosurf-Neonatal: the synthetic surfactant. Introductory symposium, 20 June 1992]. Monatsschr Kinderheilkd. 1992 Sep;140(9 [EXOSURF]):1-12. No abstract available. German.
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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?
A study testing Neurologic and neuropsychologic tests in people with Elderly Patients Undergoing Spinal Surgery, run by Yonsei University 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 28 Jan 2015. 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.
What does the primary outcome measure?
K-MMSE (time frame: change of K-MMSE from baseine to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01839227, which also lists 16 linked publications.
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 28 Jan 2015.