PNDNCT04488952
The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly
A study testing nerve block combined with general anesthesia and spinal anesthesia in people with PND, run by Shenzhen Second People's Hospital at 1 site in China.
Trial summary
Perioperative Neurocognitive Disorders(PND) is a common perioperative complication among the elderly, especially in the plastic surgery. Different anesthesia methods have different incidences of PND, but it's still unknow which is better between spinal anesthesia and nerve block combined with general anesthesia. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- PND
- What is being tested?
- nerve block combined with general anesthesia and spinal anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2020to 1 Jun 2024
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 60-85years
- ASA I-III
- Received elective surgery of unilateral lower extremity orthopedics
- The anesthesia lasted more than 2 hours
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Nanbo Luo, MD, +8615112389303, 316916645@qq.com
About this study
Official title: The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly: a Randomized Controlled Trial
Perioperative Neurocognitive Disorders(PND) is a common perioperative complication among the elderly, especially in the plastic surgery. Different anesthesia methods have different incidences of PND, but it's still unknow which is better between spinal anesthesia and nerve block combined with general anesthesia. We will apply a psychometric battery test which contain different cognitive domains to estimate the incidence of PND at a week a month and a year after surgery with different anesthesia methods. Study has showed that functional magnetic resonance imaging (fMRI) could detect a cognitive decline through spontaneous neuronal activity in the cortex and hippocampus. In our study, multi-mode imaging technology is used to conduct in-depth research on MRI and make correlation analysis with cognitive function.
- Conditions
- PND
- Being tested
- nerve block combined with general anesthesia, spinal anesthesia
- Keywords
- PND,anesthesia method, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve block combined with general anesthesiaDevice
Patients in this group receive nerve block combined with general anesthesia.
spinal anesthesiaDevice
Patients in this group receive spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| nerve block combined with general anesthesia group | Experimental | Patients in this group receive nerve block combined with general anesthesia. Receives: Device: nerve block combined with general anesthesia; Device: spinal anesthesia |
| spinal anesthesia group | Experimental | Patients in this group receive spinal anesthesia. Receives: Device: nerve block combined with general anesthesia; Device: spinal anesthesia |
| control group | Placebo comparator | This group is used to obtain the learning effect. Receives: Device: nerve block combined with general anesthesia; Device: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PND seven days after surgery
Measured: seven days after surgery
Secondary outcomes (12)
Incidence of PND one month after surgery
Measured: one month after surgery
Incidence of PND one year after surgery
Measured: one year after surgery
Hospital stay
Measured: one to two weeks after surgery
Number of patients entrance the ward of ICU after surgery
Measured: one week post-operation
Mortality rate
Measured: one year after surgery
Postoperative complications
Measured: one month post-operation
ADL of frontal lobe，temporal lobe and occipital lobe
Measured: one day pre-operation, one week post-operation
ADL of frontal lobe
Measured: one day pre-operation, one week post-operation
BOLD of the whole brain
Measured: one day pre-operation, one week post-operation
ADL of temporal lobe
Measured: one day pre-operation, one week post-operation
ADL of occipital lobe
Measured: one day pre-operation, one week post-operation
One year event-free survival
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start8 Jul 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for PNDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhiHeng Liu, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488952
- Sponsor's protocol ID
- 20193357001-XZ01
- Status last verified
- Apr 2022
- First submitted
- 22 Jul 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bittner EA, Yue Y, Xie Z. Brief review: anesthetic neurotoxicity in the elderly, cognitive dysfunction and Alzheimer's disease. Can J Anaesth. 2011 Feb;58(2):216-23. doi: 10.1007/s12630-010-9418-x. Epub 2010 Dec 21.
PubMed 21174183Yildizeli B, Ozyurtkan MO, Batirel HF, Kuscu K, Bekiroglu N, Yuksel M. Factors associated with postoperative delirium after thoracic surgery. Ann Thorac Surg. 2005 Mar;79(3):1004-9. doi: 10.1016/j.athoracsur.2004.06.022.
PubMed 15734423Mason SE, Noel-Storr A, Ritchie CW. The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and post-operative delirium: a systematic review with meta-analysis. J Alzheimers Dis. 2010;22 Suppl 3:67-79. doi: 10.3233/JAD-2010-101086.
PubMed 20858956Alkire MT, Pomfrett CJ, Haier RJ, Gianzero MV, Chan CM, Jacobsen BP, Fallon JH. Functional brain imaging during anesthesia in humans: effects of halothane on global and regional cerebral glucose metabolism. Anesthesiology. 1999 Mar;90(3):701-9. doi: 10.1097/00000542-199903000-00011.
PubMed 10078670Peng L, Xu L, Ouyang W. Role of peripheral inflammatory markers in postoperative cognitive dysfunction (POCD): a meta-analysis. PLoS One. 2013 Nov 13;8(11):e79624. doi: 10.1371/journal.pone.0079624. eCollection 2013.
PubMed 24236147Silbert B, Evered L, Scott DA, McMahon S, Choong P, Ames D, Maruff P, Jamrozik K. Preexisting cognitive impairment is associated with postoperative cognitive dysfunction after hip joint replacement surgery. Anesthesiology. 2015 Jun;122(6):1224-34. doi: 10.1097/ALN.0000000000000671.
PubMed 25859906Squire LR. Memory and the hippocampus: a synthesis from findings with rats, monkeys, and humans. Psychol Rev. 1992 Apr;99(2):195-231. doi: 10.1037/0033-295x.99.2.195.
PubMed 1594723Zola-Morgan S, Squire LR, Amaral DG. Human amnesia and the medial temporal region: enduring memory impairment following a bilateral lesion limited to field CA1 of the hippocampus. J Neurosci. 1986 Oct;6(10):2950-67. doi: 10.1523/JNEUROSCI.06-10-02950.1986.
PubMed 3760943Price CC, Tanner JJ, Schmalfuss I, Garvan CW, Gearen P, Dickey D, Heilman K, McDonagh DL, Libon DJ, Leonard C, Bowers D, Monk TG. A pilot study evaluating presurgery neuroanatomical biomarkers for postoperative cognitive decline after total knee arthroplasty in older adults. Anesthesiology. 2014 Mar;120(3):601-13. doi: 10.1097/ALN.0000000000000080.
PubMed 24534857Hole A, Terjesen T, Breivik H. Epidural versus general anaesthesia for total hip arthroplasty in elderly patients. Acta Anaesthesiol Scand. 1980 Aug;24(4):279-87. doi: 10.1111/j.1399-6576.1980.tb01549.x.
PubMed 7468115Berggren D, Gustafson Y, Eriksson B, Bucht G, Hansson LI, Reiz S, Winblad B. Postoperative confusion after anesthesia in elderly patients with femoral neck fractures. Anesth Analg. 1987 Jun;66(6):497-504.
PubMed 3578861Williams-Russo P, Sharrock NE, Mattis S, Szatrowski TP, Charlson ME. Cognitive effects after epidural vs general anesthesia in older adults. A randomized trial. JAMA. 1995 Jul 5;274(1):44-50.
PubMed 7791257Moller 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 9525362Rasmussen LS, Johnson T, Kuipers HM, Kristensen D, Siersma VD, Vila P, Jolles J, Papaioannou A, Abildstrom H, Silverstein JH, Bonal JA, Raeder J, Nielsen IK, Korttila K, Munoz L, Dodds C, Hanning CD, Moller JT; ISPOCD2(International Study of Postoperative Cognitive Dysfunction) Investigators. Does anaesthesia cause postoperative cognitive dysfunction? A randomised study of regional versus general anaesthesia in 438 elderly patients. Acta Anaesthesiol Scand. 2003 Mar;47(3):260-6. doi: 10.1034/j.1399-6576.2003.00057.x.
PubMed 12648190O'Hara DA, Duff A, Berlin JA, Poses RM, Lawrence VA, Huber EC, Noveck H, Strom BL, Carson JL. The effect of anesthetic technique on postoperative outcomes in hip fracture repair. Anesthesiology. 2000 Apr;92(4):947-57. doi: 10.1097/00000542-200004000-00011.
PubMed 10754613
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04488952
- Acronym / sponsor ID
- 20193357001-XZ01
- Conditions
- PND
- Keywords
- PND,anesthesia method, elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 28 Jul 2020 (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.
Perioperative Neurocognitive Disorders(PND) is a common perioperative complication among the elderly, especially in the plastic surgery. Different anesthesia methods have different incidences of PND, but it's still unknow which is better between spinal anesthesia and nerve block combined with general anesthesia. We will apply a psychometric battery test which contain different cognitive domains to estimate the incidence of PND at a week a month and a year after surgery with different anesthesia methods. Study has showed that functional magnetic resonance imaging (fMRI) could detect a cognitive decline through spontaneous neuronal activity in the cortex and hippocampus. In our study, multi-mode imaging technology is used to conduct in-depth research on MRI and make correlation analysis with cognitive function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nerve block combined with general anesthesia group | Experimental | Device: nerve block combined with general anesthesia, Device: spinal anesthesiaPatients in this group receive nerve block combined with general anesthesia. |
| spinal anesthesia group | Experimental | Device: nerve block combined with general anesthesia, Device: spinal anesthesiaPatients in this group receive spinal anesthesia. |
| control group | Placebo comparator | Device: nerve block combined with general anesthesia, Device: spinal anesthesiaThis group is used to obtain the learning effect. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 60-85years
- ASA I-III
- Received elective surgery of unilateral lower extremity orthopedics
- The anesthesia lasted more than 2 hours
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| nerve block combined with general anesthesiaPatients in this group receive nerve block combined with general anesthesia. | Device | control group, nerve block combined with general anesthesia group, spinal anesthesia group |
| spinal anesthesiaPatients in this group receive spinal anesthesia. | Device | control group, nerve block combined with general anesthesia group, spinal anesthesia group |
Primary outcome
Incidence of PND seven days after surgery
Time frame: seven days after surgery
12 secondary outcomes
Incidence of PND one month after surgery
Time frame: one month after surgery
Incidence of PND one year after surgery
Time frame: one year after surgery
Hospital stay
Time frame: one to two weeks after surgery
Number of patients entrance the ward of ICU after surgery
Time frame: one week post-operation
Mortality rate
Time frame: one year after surgery
Postoperative complications
Time frame: one month post-operation
ADL of frontal lobe，temporal lobe and occipital lobe
Time frame: one day pre-operation, one week post-operation
ADL of frontal lobe
Time frame: one day pre-operation, one week post-operation
BOLD of the whole brain
Time frame: one day pre-operation, one week post-operation
ADL of temporal lobe
Time frame: one day pre-operation, one week post-operation
ADL of occipital lobe
Time frame: one day pre-operation, one week post-operation
One year event-free survival
Time frame: one year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 21174183Bittner EA, Yue Y, Xie Z. Brief review: anesthetic neurotoxicity in the elderly, cognitive dysfunction and Alzheimer's disease. Can J Anaesth. 2011 Feb;58(2):216-23. doi: 10.1007/s12630-010-9418-x. Epub 2010 Dec 21.
- Background: PubMed 15734423Yildizeli B, Ozyurtkan MO, Batirel HF, Kuscu K, Bekiroglu N, Yuksel M. Factors associated with postoperative delirium after thoracic surgery. Ann Thorac Surg. 2005 Mar;79(3):1004-9. doi: 10.1016/j.athoracsur.2004.06.022.
- Background: PubMed 20858956Mason SE, Noel-Storr A, Ritchie CW. The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and post-operative delirium: a systematic review with meta-analysis. J Alzheimers Dis. 2010;22 Suppl 3:67-79. doi: 10.3233/JAD-2010-101086.
- Background: PubMed 10078670Alkire MT, Pomfrett CJ, Haier RJ, Gianzero MV, Chan CM, Jacobsen BP, Fallon JH. Functional brain imaging during anesthesia in humans: effects of halothane on global and regional cerebral glucose metabolism. Anesthesiology. 1999 Mar;90(3):701-9. doi: 10.1097/00000542-199903000-00011.
- Background: PubMed 24236147Peng L, Xu L, Ouyang W. Role of peripheral inflammatory markers in postoperative cognitive dysfunction (POCD): a meta-analysis. PLoS One. 2013 Nov 13;8(11):e79624. doi: 10.1371/journal.pone.0079624. eCollection 2013.
- Background: PubMed 25859906Silbert B, Evered L, Scott DA, McMahon S, Choong P, Ames D, Maruff P, Jamrozik K. Preexisting cognitive impairment is associated with postoperative cognitive dysfunction after hip joint replacement surgery. Anesthesiology. 2015 Jun;122(6):1224-34. doi: 10.1097/ALN.0000000000000671.
- Background: PubMed 1594723Squire LR. Memory and the hippocampus: a synthesis from findings with rats, monkeys, and humans. Psychol Rev. 1992 Apr;99(2):195-231. doi: 10.1037/0033-295x.99.2.195.
- Background: PubMed 3760943Zola-Morgan S, Squire LR, Amaral DG. Human amnesia and the medial temporal region: enduring memory impairment following a bilateral lesion limited to field CA1 of the hippocampus. J Neurosci. 1986 Oct;6(10):2950-67. doi: 10.1523/JNEUROSCI.06-10-02950.1986.
- Background: PubMed 24534857Price CC, Tanner JJ, Schmalfuss I, Garvan CW, Gearen P, Dickey D, Heilman K, McDonagh DL, Libon DJ, Leonard C, Bowers D, Monk TG. A pilot study evaluating presurgery neuroanatomical biomarkers for postoperative cognitive decline after total knee arthroplasty in older adults. Anesthesiology. 2014 Mar;120(3):601-13. doi: 10.1097/ALN.0000000000000080.
- Background: PubMed 7468115Hole A, Terjesen T, Breivik H. Epidural versus general anaesthesia for total hip arthroplasty in elderly patients. Acta Anaesthesiol Scand. 1980 Aug;24(4):279-87. doi: 10.1111/j.1399-6576.1980.tb01549.x.
- Background: PubMed 3578861Berggren D, Gustafson Y, Eriksson B, Bucht G, Hansson LI, Reiz S, Winblad B. Postoperative confusion after anesthesia in elderly patients with femoral neck fractures. Anesth Analg. 1987 Jun;66(6):497-504.
- Background: PubMed 7791257Williams-Russo P, Sharrock NE, Mattis S, Szatrowski TP, Charlson ME. Cognitive effects after epidural vs general anesthesia in older adults. A randomized trial. JAMA. 1995 Jul 5;274(1):44-50.
- Individual participant dataSharing planned: No
Related trials for PND
Not yet recruiting
Application of Perinatal Derivatives in Total Knee Arthroplasty
Total Knee Arthroplasty, Knee Osteoarthristis
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Not yet recruitingObservational study
Parallel Sequencing of Fetal Genome and RNA in the Presence of Ultrasound Warning Signs: a Complementary Approach for the Prenatal Diagnosis of Rare Diseases.
Couples Eligible for Prenatal Exome Sequencing
RecruitingObservational study
Health Economic Evaluation of Non-Invasive Prenatal Exclusion Diagnosis
Monogenic Diseases, Genetic Diseases, Inborn
RecruitingObservational study
A Study on Combined Low-pass Whole-genome and Methylome Testing of Bloody Nipple Discharge Specimens for Benign-Malignant Differentiation.
Breast Cancer, Nipple Discharge
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nerve block combined with general anesthesia and spinal anesthesia in people with PND, run by Shenzhen Second People's Hospital at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 28 Apr 2022. 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 China. 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. Some participants in this study may receive a placebo. 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?
Contact Zhiheng Liu, MD (+86-0755-83366388, 15818585570@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PND seven days after surgery (time frame: seven days after surgery). 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 NCT04488952, which also lists 24 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 Apr 2022.