Skip to content

Sevoflurane, Propofol and Desflurane on POD/POCD

Effects of Anesthetics Sevoflurane, Propofol and Desflurane on Postoperative Delirium (POD) and Postoperative Cognitive Disorder (POCD)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03326960
Enrollment
300
Registered
2017-10-31
Start date
2016-01-01
Completion date
2021-06-30
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Desflurane, Propofol, Sevoflurane

Keywords

general anesthesia, postoperative delirium, postoperative cognitive dysfunction, retinal nerve fiber layer, biomarker

Brief 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.

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.

Interventions

DRUGSevoflurane

Anesthesia maintenance with sevoflurane guided by Narcrotrend index monitoring.

DRUGPropofol

Anesthesia maintenance with propofol guided by Narcrotrend index monitoring.

DRUGDesflurane

Anesthesia maintenance with desflurane guided by Narcrotrend index monitoring.

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative deliriumAt 1st day after the surgeryPostoperative delirium will be determined by Confusion Assessment Method (CAM) at 1st postoperative day

Secondary

MeasureTime frameDescription
Postoperative deliriumAt 2nd day after the surgeryPostoperative delirium will be determined by CAM at 2nd postoperative day
Preoperative cognitive functionPreoperative cognitive function (baseline)Preoperative cognitive function will be assessed by neuropsychological battery
Postoperative cognitive dysfunctionChange from baseline cognitive dysfunction at 1 weekPostoperative cognitive dysfunction will be assessed by neuropsychological battery before and after the surgery and anesthesia
Retinal nerve fiber layer thicknessChange from baseline RNFL thickness at 3rd monthRetinal nerve fiberlayer(RNFL)thickness will be measured by optical coherence tomography (OCT) before and after surgery and anesthesia
Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)Before the surgery (baseline)vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested

Countries

China

Contacts

Primary ContactYuan Shen, M.D.,Ph.D.
kmshy@tongji.edu.cn66303649
Backup ContactZhongyong Shi, M.D., Ph.D.
szy0721@126.com18701915271

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026