Cerebral Oxygen SaturationNCT05615480

Effect of Cerebral Oxygen Saturation Monitoring on POCD of Elderly Patients Undergoing Shoulder Arthroscopy

A study of Cerebral Oxygen Saturation and Postoperative Cognitive Function, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 60 to 79 years
Conditions the study is for: Cerebral Oxygen Saturation, Postoperative Cognitive Function
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: No sites listed yet
Study dates: 15 May 2023to 30 Jun 2026
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 60 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing elective shoulder arthroscopic surgery under general anesthesia combined with brachial plexus block;
ASA grade ≤ grade III;
Patients Can communicate normally, can cooperate and complete cognitive function test;
Patients volunteered and signed informed consent.

Who cannot join

BMI < 18 or > 27 kg / m2;
Previous history of dementia, psychosis or other central nervous system diseases or mental diseases, such as cerebral infarction, stroke, Parkinson's disease, etc;
Patients taking sedatives or antidepressants;
Alcoholics or drug addicts;
Illiteracy, severe hearing or visual impairment;
Patients with cognitive impairment before operation (MMSE score < 23);
Patients with peripheral vascular diseases and contraindication of arterial puncture and catheterization;
Patients unable to carry out long-term follow-up or poor compliance.

About this study

Official title: Effect of Controlled Hypotension Guided by Cerebral Oxygen Saturation Monitoring on Postoperative Cognitive Function of Elderly Patients Undergoing Shoulder Arthroscopy

To observe whether adjusting the level of intraoperative controlled hypotension through cerebral oxygen saturation monitoring can improve postoperative cognitive function(POCD) and reduce postoperative neurological complications, a prospective randomized controlled study method will be used in this study. 400 elderly patients undergoing shoulder arthroscopic surgery under general anesthesia combined with brachial plexus block will be selected. They will be randomly divided into control group and experimental group according to whether cerebral oxygen saturation monitoring was used during the operation. The control group maintain the target blood pressure only according to the controlled hypotension guideline, and the experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring. The general condition, operation, anesthesia and hospitalization related data of the patients will be recorded.

Read the detailed description

Cognitive function will be evaluated within 3 days before operation and 3 days, 14 days and 3 months after operation. Delirium and VAS pain score will be evaluated 24 hours after operation. Venous blood will be taken before operation and 24 hours after operation to detect cognitive related markers and inflammatory factors. In addition, 10 blood samples of patients in each group were selected for RNA omics test. One month, six months and 12 months after operation, cognitive function was evaluated by cognitive function telephone questionnaire (TICS-M), and the ability of daily living was evaluated by IDAL. In addition, 20 non-surgical patients were selected for cognitive function evaluation at the same time point as the exercise effect of POCD detection.

Conditions: Cerebral Oxygen Saturation, Postoperative Cognitive Function
Being tested: Controlled hypotension guided by cerebral oxygen saturation monitoring
Keywords: controlled hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Controlled hypotension guided by cerebral oxygen saturation monitoringOther
In this group, intraoperative monitoring of cerebral oxygen saturation will be used. When the cerebral oxygen saturation decreased by 20% ~ 25% compared with the baseline for 300 seconds without improvement, or the cerebral oxygen saturation decreased by 25% ~ 30% compared with the baseline for 180 seconds without improvement, intervention would be carried out. When the cerebral oxygen saturation decreased by 30% compared with the baseline, immediate intervention would be carried out. The intervention measures were intravenous administration of deoxyepinephrine 50 ~ 100 μg or ephedrine 5 ~ 10mg, which can be administered multiple times until the cerebral oxygen saturation reaches more than 80% of the baseline.

Study groups in NCT05615480
Study group	Role	What they receive
Control group	No intervention	The control group maintain the target blood pressure only according to the controlled hypotension guideline.
Experimental group	Experimental	The experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring. Receives: Other: Controlled hypotension guided by cerebral oxygen saturation monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of postoperative cognitive dysfunction(POCD) 3 days after operation
The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test.
Measured: 3 days after operation

Secondary outcomes (6)

Incidence of postoperative cognitive dysfunction(POCD) 14 days after operation
The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test.
Measured: 14 days after operation
Incidence of postoperative cognitive dysfunction(POCD) 3 months after operation
The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test.
Measured: 3 months after operation
Expression changes of cognitive function related markers 24 hours after operation
Patients consented on blood sampling receive marker analysis from blood（S100β、NSE and IL-6).
Measured: 24 hours after operation
Hospital stay
Hospital stay
Measured: through hospitalization period, an average of 15 day
Hospital expenses
Hospital expenses
Measured: through hospitalization period, an average of 15 day
Perioperative complications
Complications during the surgical period
Measured: 1 day (during the surgical period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 202330 Jun 2026

First posted14 Nov 2022
Study start15 May 2023 (estimated)
Primary completion30 Jun 2025 (estimated)
Study completion30 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Cerebral Oxygen SaturationStudies of the same condition, open and under way.
More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Recruited patients will be randomly divided into control group and experimental group according to whether cerebral oxygen saturation monitoring was used during the operation. The control group maintain the target blood pressure only according to the controlled hypotension guideline, and the experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05615480
Sponsor's protocol ID: 2021-KY-009-001
Status last verified: May 2022
First submitted: 9 May 2022
Last updated: 13 Apr 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Daiello LA, Racine AM, Yun Gou R, Marcantonio ER, Xie Z, Kunze LJ, Vlassakov KV, Inouye SK, Jones RN, Alsop D, Travison T, Arnold S, Cooper Z, Dickerson B, Fong T, Metzger E, Pascual-Leone A, Schmitt EM, Shafi M, Cavallari M, Dai W, Dillon ST, McElhaney J, Guttmann C, Hshieh T, Kuchel G, Libermann T, Ngo L, Press D, Saczynski J, Vasunilashorn S, O'Connor M, Kimchi E, Strauss J, Wong B, Belkin M, Ayres D, Callery M, Pomposelli F, Wright J, Schermerhorn M, Abrantes T, Albuquerque A, Bertrand S, Brown A, Callahan A, D'Aquila M, Dowal S, Fox M, Gallagher J, Anna Gersten R, Hodara A, Helfand B, Inloes J, Kettell J, Kuczmarska A, Nee J, Nemeth E, Ochsner L, Palihnich K, Parisi K, Puelle M, Rastegar S, Vella M, Xu G, Bryan M, Guess J, Enghorn D, Gross A, Gou Y, Habtemariam D, Isaza I, Kosar C, Rockett C, Tommet D, Gruen T, Ross M, Tasker K, Gee J, Kolanowski A, Pisani M, de Rooij S, Rogers S, Studenski S, Stern Y, Whittemore A, Gottlieb G, Orav J, Sperling R; SAGES Study Group*. Postoperative Delirium and Postoperative Cognitive Dysfunction: Overlap and Divergence. Anesthesiology. 2019 Sep;131(3):477-491. doi: 10.1097/ALN.0000000000002729.
PubMed 31166241
Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569.
PubMed 19225398
Evered LA, Silbert BS, Scott DA, Maruff P, Ames D. Prevalence of Dementia 7.5 Years after Coronary Artery Bypass Graft Surgery. Anesthesiology. 2016 Jul;125(1):62-71. doi: 10.1097/ALN.0000000000001143.
PubMed 27127919
Krenk L, Rasmussen LS, Kehlet H. New insights into the pathophysiology of postoperative cognitive dysfunction. Acta Anaesthesiol Scand. 2010 Sep;54(8):951-6. doi: 10.1111/j.1399-6576.2010.02268.x. Epub 2010 Jul 12.
PubMed 20626359
Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
PubMed 9525362
Newman MF, Grocott HP, Mathew JP, White WD, Landolfo K, Reves JG, Laskowitz DT, Mark DB, Blumenthal JA; Neurologic Outcome Research Group and the Cardiothoracic Anesthesia Research Endeavors (CARE) Investigators of the Duke Heart Center. Report of the substudy assessing the impact of neurocognitive function on quality of life 5 years after cardiac surgery. Stroke. 2001 Dec 1;32(12):2874-81. doi: 10.1161/hs1201.099803.
PubMed 11739990
Needham MJ, Webb CE, Bryden DC. Postoperative cognitive dysfunction and dementia: what we need to know and do. Br J Anaesth. 2017 Dec 1;119(suppl_1):i115-i125. doi: 10.1093/bja/aex354.
PubMed 29161395
Tang L, Kazan R, Taddei R, Zaouter C, Cyr S, Hemmerling TM. Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction. Br J Anaesth. 2012 Apr;108(4):623-9. doi: 10.1093/bja/aer501. Epub 2012 Feb 5.
PubMed 22311364
Kim J, Shim JK, Song JW, Kim EK, Kwak YL. Postoperative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery. Anesth Analg. 2016 Aug;123(2):436-44. doi: 10.1213/ANE.0000000000001352.
PubMed 27285000
de Tournay-Jette E, Dupuis G, Bherer L, Deschamps A, Cartier R, Denault A. The relationship between cerebral oxygen saturation changes and postoperative cognitive dysfunction in elderly patients after coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):95-104. doi: 10.1053/j.jvca.2010.03.019. Epub 2010 Jul 22.
PubMed 20650659
Nilsson PM. The J-shaped curve in secondary prevention: shall clinical practice change? Hypertension. 2012 Jan;59(1):8-9. doi: 10.1161/HYPERTENSIONAHA.111.182774. Epub 2011 Nov 7. No abstract available.
PubMed 22068873
Erdem AF, Kayabasoglu G, Tas Tuna A, Palabiyik O, Tomak Y, Beyaz SG. Effect of controlled hypotension on regional cerebral oxygen saturation during rhinoplasty: a prospective study. J Clin Monit Comput. 2016 Oct;30(5):655-60. doi: 10.1007/s10877-015-9768-6. Epub 2015 Sep 10.
PubMed 26358703
Cox RM, Jamgochian GC, Nicholson K, Wong JC, Namdari S, Abboud JA. The effectiveness of cerebral oxygenation monitoring during arthroscopic shoulder surgery in the beach chair position: a randomized blinded study. J Shoulder Elbow Surg. 2018 Apr;27(4):692-700. doi: 10.1016/j.jse.2017.11.004. Epub 2018 Feb 1.
PubMed 29396097
Salazar D, Sears BW, Aghdasi B, Only A, Francois A, Tonino P, Marra G. Cerebral desaturation events during shoulder arthroscopy in the beach chair position: patient risk factors and neurocognitive effects. J Shoulder Elbow Surg. 2013 Sep;22(9):1228-35. doi: 10.1016/j.jse.2012.12.036. Epub 2013 Feb 15.
PubMed 23415820

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 4
Effects of Ondansetron Timing During Spinal Anesthesia for Urologic Surgery
Spinal Anesthesia-Induced Hypotension, Cerebral Oxygenation
RecruitingObservational study
Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery
Lumbar Disc Herniation, Respiratory Mechanics
Not yet recruitingObservational study
Cerebral Oximetry During Awake Carotid Endarterectomy
Carotid Stenosis, Carotid Artery Diseases
Not yet recruiting
Effect of Left Paratracheal Pressure on Cerebral Oxygenation During General Anesthesia
Cerebral Oxygenation
RecruitingPhase 4
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
Neonates and Preterm Infants, Infant Respiratory Distress Syndrome

All Cerebral Oxygen Saturation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Controlled Hypotension Guided by Cerebral Oxygen Saturation Monitoring on Postoperative Cognitive Function of Elderly Patients Undergoing Shoulder Arthroscopy
ClinicalTrials.gov ID: NCT05615480
Acronym / sponsor ID: 2021-KY-009-001
Conditions: Cerebral Oxygen Saturation, Postoperative Cognitive Function
Keywords: controlled hypotension
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 400 participants (estimated)
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
Study start: 15 May 2023 (estimated)
Primary completion: 30 Jun 2025 (estimated)
Study completion: 30 Jun 2026 (estimated)
First posted: 14 Nov 2022 (actual)
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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Recruited patients will be randomly divided into control group and experimental group according to whether cerebral oxygen saturation monitoring was used during the operation. The control group maintain the target blood pressure only according to the controlled hypotension guideline, and the experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring.

Arm	Type	Receives
Control group	No intervention	–The control group maintain the target blood pressure only according to the controlled hypotension guideline.
Experimental group	Experimental	Other: Controlled hypotension guided by cerebral oxygen saturation monitoringThe experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring.

Who may qualify

Ages: 60 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients undergoing elective shoulder arthroscopic surgery under general anesthesia combined with brachial plexus block;
ASA grade ≤ grade III;
Patients Can communicate normally, can cooperate and complete cognitive function test;
Patients volunteered and signed informed consent.

Key exclusion criteria (8 listed)

BMI < 18 or > 27 kg / m2;
Previous history of dementia, psychosis or other central nervous system diseases or mental diseases, such as cerebral infarction, stroke, Parkinson's disease, etc;
Patients taking sedatives or antidepressants;
Alcoholics or drug addicts;
Illiteracy, severe hearing or visual impairment;

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
Controlled hypotension guided by cerebral oxygen saturation monitoringIn this group, intraoperative monitoring of cerebral oxygen saturation will be used. When the cerebral oxygen saturation decreased by 20% ~ 25% compared with the baseline for 300 seconds without improvement, or the cerebral oxygen saturation decreased by 25% ~ 30% compared with the baseline for 180 seconds without improvement, intervention would be carried out. When the cerebral oxygen saturation decreased by 30% compared with the baseline, immediate intervention would be carried out. The intervention measures were intravenous administration of deoxyepinephrine 50 ~ 100 μg or ephedrine 5 ~ 10mg, which can be administered multiple times until the cerebral oxygen saturation reaches more than 80% of the baseline.	Other	Experimental group

Primary outcome

Incidence of postoperative cognitive dysfunction(POCD) 3 days after operation
Time frame: 3 days after operation
The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test.

6 secondary outcomes

Incidence of postoperative cognitive dysfunction(POCD) 14 days after operation
Time frame: 14 days after operation
Incidence of postoperative cognitive dysfunction(POCD) 3 months after operation
Time frame: 3 months after operation
Expression changes of cognitive function related markers 24 hours after operation
Time frame: 24 hours after operation
Hospital stay
Time frame: through hospitalization period, an average of 15 day
Hospital expenses
Time frame: through hospitalization period, an average of 15 day
Perioperative complications
Time frame: 1 day (during the surgical period)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
Background: PubMed 31166241Daiello LA, Racine AM, Yun Gou R, Marcantonio ER, Xie Z, Kunze LJ, Vlassakov KV, Inouye SK, Jones RN, Alsop D, Travison T, Arnold S, Cooper Z, Dickerson B, Fong T, Metzger E, Pascual-Leone A, Schmitt EM, Shafi M, Cavallari M, Dai W, Dillon ST, McElhaney J, Guttmann C, Hshieh T, Kuchel G, Libermann T, Ngo L, Press D, Saczynski J, Vasunilashorn S, O'Connor M, Kimchi E, Strauss J, Wong B, Belkin M, Ayres D, Callery M, Pomposelli F, Wright J, Schermerhorn M, Abrantes T, Albuquerque A, Bertrand S, Brown A, Callahan A, D'Aquila M, Dowal S, Fox M, Gallagher J, Anna Gersten R, Hodara A, Helfand B, Inloes J, Kettell J, Kuczmarska A, Nee J, Nemeth E, Ochsner L, Palihnich K, Parisi K, Puelle M, Rastegar S, Vella M, Xu G, Bryan M, Guess J, Enghorn D, Gross A, Gou Y, Habtemariam D, Isaza I, Kosar C, Rockett C, Tommet D, Gruen T, Ross M, Tasker K, Gee J, Kolanowski A, Pisani M, de Rooij S, Rogers S, Studenski S, Stern Y, Whittemore A, Gottlieb G, Orav J, Sperling R; SAGES Study Group*. Postoperative Delirium and Postoperative Cognitive Dysfunction: Overlap and Divergence. Anesthesiology. 2019 Sep;131(3):477-491. doi: 10.1097/ALN.0000000000002729.
Background: PubMed 19225398Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569.
Background: PubMed 27127919Evered LA, Silbert BS, Scott DA, Maruff P, Ames D. Prevalence of Dementia 7.5 Years after Coronary Artery Bypass Graft Surgery. Anesthesiology. 2016 Jul;125(1):62-71. doi: 10.1097/ALN.0000000000001143.
Background: PubMed 20626359Krenk L, Rasmussen LS, Kehlet H. New insights into the pathophysiology of postoperative cognitive dysfunction. Acta Anaesthesiol Scand. 2010 Sep;54(8):951-6. doi: 10.1111/j.1399-6576.2010.02268.x. Epub 2010 Jul 12.
Background: PubMed 9525362Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
Background: PubMed 11739990Newman MF, Grocott HP, Mathew JP, White WD, Landolfo K, Reves JG, Laskowitz DT, Mark DB, Blumenthal JA; Neurologic Outcome Research Group and the Cardiothoracic Anesthesia Research Endeavors (CARE) Investigators of the Duke Heart Center. Report of the substudy assessing the impact of neurocognitive function on quality of life 5 years after cardiac surgery. Stroke. 2001 Dec 1;32(12):2874-81. doi: 10.1161/hs1201.099803.
Background: PubMed 29161395Needham MJ, Webb CE, Bryden DC. Postoperative cognitive dysfunction and dementia: what we need to know and do. Br J Anaesth. 2017 Dec 1;119(suppl_1):i115-i125. doi: 10.1093/bja/aex354.
Background: PubMed 22311364Tang L, Kazan R, Taddei R, Zaouter C, Cyr S, Hemmerling TM. Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction. Br J Anaesth. 2012 Apr;108(4):623-9. doi: 10.1093/bja/aer501. Epub 2012 Feb 5.
Background: PubMed 27285000Kim J, Shim JK, Song JW, Kim EK, Kwak YL. Postoperative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery. Anesth Analg. 2016 Aug;123(2):436-44. doi: 10.1213/ANE.0000000000001352.
Background: PubMed 20650659de Tournay-Jette E, Dupuis G, Bherer L, Deschamps A, Cartier R, Denault A. The relationship between cerebral oxygen saturation changes and postoperative cognitive dysfunction in elderly patients after coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):95-104. doi: 10.1053/j.jvca.2010.03.019. Epub 2010 Jul 22.
Background: PubMed 22068873Nilsson PM. The J-shaped curve in secondary prevention: shall clinical practice change? Hypertension. 2012 Jan;59(1):8-9. doi: 10.1161/HYPERTENSIONAHA.111.182774. Epub 2011 Nov 7. No abstract available.
Background: PubMed 26358703Erdem AF, Kayabasoglu G, Tas Tuna A, Palabiyik O, Tomak Y, Beyaz SG. Effect of controlled hypotension on regional cerebral oxygen saturation during rhinoplasty: a prospective study. J Clin Monit Comput. 2016 Oct;30(5):655-60. doi: 10.1007/s10877-015-9768-6. Epub 2015 Sep 10.
Individual participant dataSharing planned: No

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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.

Questions about this trial

What is this clinical trial studying?

A study of Cerebral Oxygen Saturation and Postoperative Cognitive Function, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Incidence of postoperative cognitive dysfunction(POCD) 3 days after operation (time frame: 3 days after operation). 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 NCT05615480, which also lists 14 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 13 Apr 2023.