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Status unknownNCT03326960Updated Oct 22, 2020

Sevoflurane, Propofol and Desflurane on POD/POCD

An observational study in Sevoflurane, Propofol and Desflurane, sponsored by Shanghai 10th People's Hospital. Status unknown at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by Shanghai 10th People's Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 185 studies in Emergence Delirium with a site in China — 64 open to participants now, 65 under way, 1 of them phase 3. Emergence Delirium · China.

Planned enrollment
36th of 74
300 · median 300
Started
2016
with 4 others
Observational
74 of 185
24 open now
Registered
21st of 185
by date

Among the 185 studies in Emergence Delirium with a site in China, this one is the 36th largest by planned enrollment of the 74 observational ones that give a count, is one of 5 that started in 2016, is one of 74 observational ones, and was the 21st registered.

Emergence Delirium

752 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.

Browse Emergence Delirium studies →

Open to participants now

64 of the 185 studies in Emergence Delirium with a site in China are open now. Recruiting first, the newest first:

59 more — sign in →

All 64 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 143 Emergence Delirium studies recruiting now, 79 (55%) set no upper age limit and 44 (31%) stop at 75 or younger; 34 take children under 18; 24 take healthy volunteers.

This study: 60 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 185 studies in Emergence Delirium with a site in China, or all of them as a file.
02

Study 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) 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.

03

Conditions studied

  • Sevoflurane
  • Propofol
  • Desflurane

Keywords

  • general anesthesia
  • postoperative delirium
  • postoperative cognitive dysfunction
  • retinal nerve fiber layer
  • biomarker
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 60 years old or older
  • Chinese Mandarin as the native language
  • scheduled to undergo hip/knee surgery under general anesthesia
  • (ASA) class I-Ⅲ

Exclusion criteria

Exclusion Criteria:

  • Prior diagnoses of neurological diseases according to ICD-10
  • History of severe psychiatric disorders according to
  • Visual or auditory defects
  • Participating in the investigation of another study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Sevoflurane

    Patients in Sevoflurane group are maintained with sevoflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring.

    Drug: Sevoflurane

  • Propofol

    Patients in Propofol group are maintained with propofol through intravenous administration guided by Narcrotrend index monitoring.

    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.

    Drug: Desflurane

Interventions

  • Anesthesia maintenance with sevoflurane guided by Narcrotrend index monitoring.

  • Anesthesia maintenance with propofol guided by Narcrotrend index monitoring.

  • Anesthesia maintenance with desflurane guided by Narcrotrend index monitoring.

06

What researchers measure

Primary outcomes

  1. Postoperative delirium

    Postoperative delirium will be determined by Confusion Assessment Method (CAM) at 1st postoperative day

    Time frame: At 1st day after the surgery

Secondary outcomes

  1. Postoperative delirium

    Postoperative delirium will be determined by CAM at 2nd postoperative day

    Time frame: At 2nd day after the surgery

  2. Postoperative delirium

    Postoperative delirium will be determined by CAM at 3rd postoperative day

    Time frame: At 3rd day after the surgery

  3. Preoperative cognitive function

    Preoperative cognitive function will be assessed by neuropsychological battery

    Time frame: Preoperative cognitive function (baseline)

  4. Postoperative cognitive dysfunction

    Postoperative cognitive dysfunction will be assessed by neuropsychological battery before and after the surgery and anesthesia

    Time frame: Change from baseline cognitive dysfunction at 1 week

  5. Postoperative cognitive dysfunction

    Postoperative cognitive dysfunction will be assessed by neuropsychological battery

    Time frame: Change from baseline cognitive dysfunction at 3rd month

  6. Retinal nerve fiber layer thickness

    Retinal nerve fiberlayer(RNFL)thickness will be measured by optical coherence tomography (OCT) before and after surgery and anesthesia

    Time frame: Change from baseline RNFL thickness at 3rd month

  7. 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

    Time frame: Before the surgery (baseline)

  8. 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

    Time frame: At 1st day after the surgery

  9. 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

    Time frame: At 2nd day after the surgery

  10. 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

    Time frame: At 3rd day after the surgery

07

Study locations

1 of 1 sites recruiting
  • Shanghai 10th People's Hospital
    Shanghai, Shanghai 200072, China
    Recruiting
08

References and documents

Publications

  • Vlisides P, Xie Z. Neurotoxicity of general anesthetics: an update. Curr Pharm Des. 2012;18(38):6232-40. doi: 10.2174/138161212803832344. PubMed 22762477 ↗
  • Witlox 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 20664045 ↗
  • Gleason 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 26352694 ↗
  • Inouye 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 23992774 ↗
  • Pandharipande 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2016 (actual). Primary completion is estimated for Jun 2021, 65 months after the start.

Of 180 non-industry observational studies under Emergence Delirium, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 65 months is above that.

Counting every sponsor, half of 180 studies reached it within 21 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2017
First posted
Oct 31, 2017
StartActual
Jan 1, 2016
Primary completionEst.
Jun 30, 2021
CompletionEst.
Jun 30, 2021
Last update
Oct 22, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03326960
Responsible party
Yuan Shen, MD, PhD (Head of Psychiatry, Shanghai 10th People's Hospital) — Principal investigator
First posted
Oct 31, 2017
Start date
Jan 1, 2016
Primary completion
Jun 30, 2021 (estimated)
Completion
Jun 30, 2021 (estimated)
Last update
Oct 22, 2020

Study contacts

Yuan Shen, M.D.,Ph.D.
Contact
kmshy@tongji.edu.cn
66303649
Zhongyong Shi, M.D., Ph.D.
Contact
szy0721@126.com
18701915271
Yuan Shen, M.D.,Ph.D
principal investigator · Shanghai 10th People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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