SevofluraneNCT03326960
Sevoflurane, Propofol and Desflurane on POD/POCD
An observational study of Sevoflurane and Propofol, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The investigators will perform clinical studies to test the hypothesis that participants who have total hip/knee replacement under sevoflurane, propofol or desflurane anesthesia will have different effects on the incidence and severity of POD/POCD, and POD/POCD is associated with retinal nerve fiber layer (RNFL)… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sevoflurane, Propofol, Desflurane
- What is being tested?
- Sevoflurane, Propofol and Desflurane
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 30 Jun 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, aged 60 years old or older, who admitted to the Department of Orthopedics at Shanghai 10th People's Hospital and had been scheduled to undergo knee or hip fractures were screened and asked to participate in the study.
Who may be able to join
- 60 years old or older
- Chinese Mandarin as the native language
- scheduled to undergo hip/knee surgery under general anesthesia
- American Society of Anesthesiologists (ASA) class I-Ⅲ
Who cannot join
- Prior diagnoses of neurological diseases according to ICD-10
- History of severe psychiatric disorders according to DSM-IV
- Visual or auditory defects
- Participating in the investigation of another study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200072
Yanxia Guo, M.D., 021-65982875, guoyx_2000@tongji.edu.cn
About this study
Official title: Effects of Anesthetics Sevoflurane, Propofol and Desflurane on Postoperative Delirium (POD) and Postoperative Cognitive Disorder (POCD)
The investigators will perform clinical studies to test the hypothesis that participants who have total hip/knee replacement under sevoflurane, propofol or desflurane anesthesia will have different effects on the incidence and severity of POD/POCD, and POD/POCD is associated with retinal nerve fiber layer (RNFL) thickness, as well as Serum level of vitamin B12, folic acid, homocysteine and human myeloid differentiation protein-2 (MD-2s). The investigators plan to perform the studies in 300 participants at Shanghai 10th People's Hospital.
Read the detailed description
Postoperative delirium (POD) and postoperative cognitive disorder (POCD) are the most common complications of geriatric surgical patients, which could cause long-term social dysfunction, high mortality and increased medical cost. Currently, there is no efficient biomarker for POD/POCD, and it also remains largely unknown whether different anesthesia might lead to different incidence and severity of POD/POCD. The investigator's previous studies showed that thickness of retinal nerve fiber layer thickness (RNFL-T) measured by optical coherence tomography (OCT) was associated with POD/POCD; change of RNFL thickness (RNFL-C) in certain period correlated with cognitive deterioration. Thus, the investigators consider that RNFL might be a potential biomarker of POD/POCD. In the proposed large-scale longitudinal studies, the investigators will clinically validate RNF-LT as pre-operative POD/POCD biomarker, and RNFL-C as post-operative biomarker of POD/POCD. Finally, the investigators will compare the effects of surgery (total hip/knee replacement) under general anesthesia with sevoflurane, propofol and desflurane on the incidence and severity of POD/POCD in patients. Results from the proposed studies will likely establish RNFL as a potential POD/POCD biomarker, promote the clinical utilization of OCT-RNFL in early screening and outcome prediction of POD/POCD, and finally optimize anesthesia care of geriatric surgical patients to avoid or reduce POD/POCD incidence. These findings will lead to better postoperative outcomes of geriatric patients.
- Conditions
- Sevoflurane, Propofol, Desflurane
- Being tested
- Sevoflurane, Propofol, Desflurane
- Keywords
- general anesthesia, postoperative delirium, postoperative cognitive dysfunction, retinal nerve fiber layer, biomarker
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Anesthesia maintenance with sevoflurane guided by Narcrotrend index monitoring.
PropofolDrug
Anesthesia maintenance with propofol guided by Narcrotrend index monitoring.
DesfluraneDrug
Anesthesia maintenance with desflurane guided by Narcrotrend index monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Patients in Sevoflurane group are maintained with sevoflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring. Receives: Drug: Sevoflurane | |
| Propofol | Patients in Propofol group are maintained with propofol through intravenous administration guided by Narcrotrend index monitoring. Receives: Drug: Propofol | |
| Desflurane | Patients in Desflurane group are maintained with desflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
Postoperative delirium will be determined by Confusion Assessment Method (CAM) at 1st postoperative day
Measured: At 1st day after the surgery
Secondary outcomes (10)
Postoperative delirium
Postoperative delirium will be determined by CAM at 2nd postoperative day
Measured: At 2nd day after the surgery
Postoperative delirium
Postoperative delirium will be determined by CAM at 3rd postoperative day
Measured: At 3rd day after the surgery
Preoperative cognitive function
Preoperative cognitive function will be assessed by neuropsychological battery
Measured: Preoperative cognitive function (baseline)
Postoperative cognitive dysfunction
Postoperative cognitive dysfunction will be assessed by neuropsychological battery before and after the surgery and anesthesia
Measured: Change from baseline cognitive dysfunction at 1 week
Postoperative cognitive dysfunction
Postoperative cognitive dysfunction will be assessed by neuropsychological battery
Measured: Change from baseline cognitive dysfunction at 3rd month
Retinal nerve fiber layer thickness
Retinal nerve fiberlayer（RNFL）thickness will be measured by optical coherence tomography (OCT) before and after surgery and anesthesia
Measured: Change from baseline RNFL thickness at 3rd month
Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)
vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested
Measured: Before the surgery (baseline)
Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)
vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested
Measured: At 1st day after the surgery
Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)
vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested
Measured: At 2nd day after the surgery
Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)
vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested
Measured: At 3rd day after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Jan 2016
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SevofluraneStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Yuan Shen, MD, PhD, Shanghai 10th People's Hospital
- Investigators
- Yuan Shen, M.D.,Ph.D, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326960
- Sponsor's protocol ID
- dsyy002
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2017
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vlisides P, Xie Z. Neurotoxicity of general anesthetics: an update. Curr Pharm Des. 2012;18(38):6232-40. doi: 10.2174/138161212803832344.
PubMed 22762477Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.
PubMed 20664045Gleason LJ, Schmitt EM, Kosar CM, Tabloski P, Saczynski JS, Robinson T, Cooper Z, Rogers SO Jr, Jones RN, Marcantonio ER, Inouye SK. Effect of Delirium and Other Major Complications on Outcomes After Elective Surgery in Older Adults. JAMA Surg. 2015 Dec;150(12):1134-40. doi: 10.1001/jamasurg.2015.2606.
PubMed 26352694Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
PubMed 23992774Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
PubMed 24088092
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anesthetics Sevoflurane, Propofol and Desflurane on Postoperative Delirium (POD) and Postoperative Cognitive Disorder (POCD)
- ClinicalTrials.gov ID
- NCT03326960
- Acronym / sponsor ID
- dsyy002
- Conditions
- Sevoflurane, Propofol, Desflurane
- Keywords
- general anesthesia, postoperative delirium, postoperative cognitive dysfunction, retinal nerve fiber layer, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 31 Oct 2017 (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.
The investigators will perform clinical studies to test the hypothesis that participants who have total hip/knee replacement under sevoflurane, propofol or desflurane anesthesia will have different effects on the incidence and severity of POD/POCD, and POD/POCD is associated with retinal nerve fiber layer (RNFL) thickness, as well as Serum level of vitamin B12, folic acid, homocysteine and human myeloid differentiation protein-2 (MD-2s). The investigators plan to perform the studies in 300 participants at Shanghai 10th People's Hospital.
Detailed description
Postoperative delirium (POD) and postoperative cognitive disorder (POCD) are the most common complications of geriatric surgical patients, which could cause long-term social dysfunction, high mortality and increased medical cost. Currently, there is no efficient biomarker for POD/POCD, and it also remains largely unknown whether different anesthesia might lead to different incidence and severity of POD/POCD. The investigator's previous studies showed that thickness of retinal nerve fiber layer thickness (RNFL-T) measured by optical coherence tomography (OCT) was associated with POD/POCD; change of RNFL thickness (RNFL-C) in certain period correlated with cognitive deterioration. Thus, the investigators consider that RNFL might be a potential biomarker of POD/POCD. In the proposed large-scale longitudinal studies, the investigators will clinically validate RNF-LT as pre-operative POD/POCD biomarker, and RNFL-C as post-operative biomarker of POD/POCD. Finally, the investigators will compare the effects of surgery (total hip/knee replacement) under general anesthesia with sevoflurane, propofol and desflurane on the incidence and severity of POD/POCD in patients. Results from the proposed studies will likely establish RNFL as a potential POD/POCD biomarker, promote the clinical utilization of OCT-RNFL in early screening and outcome prediction of POD/POCD, and finally optimize anesthesia care of geriatric surgical patients to avoid or reduce POD/POCD incidence. These findings will lead to better postoperative outcomes of geriatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | – | Drug: SevofluranePatients in Sevoflurane group are maintained with sevoflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring. |
| Propofol | – | Drug: PropofolPatients in Propofol group are maintained with propofol through intravenous administration guided by Narcrotrend index monitoring. |
| Desflurane | – | Drug: DesfluranePatients in Desflurane group are maintained with desflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, aged 60 years old or older, who admitted to the Department of Orthopedics at Shanghai 10th People's Hospital and had been scheduled to undergo knee or hip fractures were screened and asked to participate in the study.
Key inclusion criteria (4 listed)
- 60 years old or older
- Chinese Mandarin as the native language
- scheduled to undergo hip/knee surgery under general anesthesia
- American Society of Anesthesiologists (ASA) class I-Ⅲ
Key exclusion criteria (4 listed)
- Prior diagnoses of neurological diseases according to ICD-10
- History of severe psychiatric disorders according to DSM-IV
- Visual or auditory defects
- Participating in the investigation of another study
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 |
|---|---|---|
| SevofluraneAnesthesia maintenance with sevoflurane guided by Narcrotrend index monitoring. | Drug | Sevoflurane |
| PropofolAnesthesia maintenance with propofol guided by Narcrotrend index monitoring. | Drug | Propofol |
| DesfluraneAnesthesia maintenance with desflurane guided by Narcrotrend index monitoring. | Drug | Desflurane |
Primary outcome
Postoperative delirium
Time frame: At 1st day after the surgery
Postoperative delirium will be determined by Confusion Assessment Method (CAM) at 1st postoperative day
10 secondary outcomes
Postoperative delirium
Time frame: At 2nd day after the surgery
Postoperative delirium
Time frame: At 3rd day after the surgery
Preoperative cognitive function
Time frame: Preoperative cognitive function (baseline)
Postoperative cognitive dysfunction
Time frame: Change from baseline cognitive dysfunction at 1 week
Postoperative cognitive dysfunction
Time frame: Change from baseline cognitive dysfunction at 3rd month
Retinal nerve fiber layer thickness
Time frame: Change from baseline RNFL thickness at 3rd month
Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)
Time frame: Before the surgery (baseline)
Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)
Time frame: At 1st day after the surgery
Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)
Time frame: At 2nd day after the surgery
Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)
Time frame: At 3rd day after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 22762477Vlisides P, Xie Z. Neurotoxicity of general anesthetics: an update. Curr Pharm Des. 2012;18(38):6232-40. doi: 10.2174/138161212803832344.
- Background: PubMed 20664045Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.
- Background: PubMed 26352694Gleason LJ, Schmitt EM, Kosar CM, Tabloski P, Saczynski JS, Robinson T, Cooper Z, Rogers SO Jr, Jones RN, Marcantonio ER, Inouye SK. Effect of Delirium and Other Major Complications on Outcomes After Elective Surgery in Older Adults. JAMA Surg. 2015 Dec;150(12):1134-40. doi: 10.1001/jamasurg.2015.2606.
- Background: PubMed 23992774Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
- Background: PubMed 24088092Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
- Individual participant dataSharing planned: Undecided
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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.
Yuan Shen, M.D.,Ph.D principal investigator
Shanghai 10th People's Hospital
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 Sevoflurane and Propofol, run by Shanghai 10th 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 4 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 22 Oct 2020. 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. 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 Yuan Shen, M.D.,Ph.D. (66303649, kmshy@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: At 1st day after the 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 NCT03326960, which also lists 5 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 22 Oct 2020.