Sevoflurane, Propofol and Desflurane on POD/POCD

• Conditions: Propofol; Sevoflurane; Desflurane
• Interventions: Drug: Sevoflurane; Drug: Propofol; Drug: Desflurane

• Registration Number: NCT03326960
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2017-10-06
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-10-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Sevoflurane	Patients in Sevoflurane group are maintained with sevoflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring.
Propofol	Propofol	Patients in Propofol group are maintained with propofol through intravenous administration guided by Narcrotrend index monitoring.
Desflurane	Desflurane	Patients in Desflurane group are maintained with desflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring.

Primary Outcome Measures

Name	Time	Method
Postoperative delirium	At 1st day after the surgery	Postoperative delirium will be determined by Confusion Assessment Method (CAM) at 1st postoperative day

Secondary Outcome Measures

Name	Time	Method
Postoperative delirium	At 3rd day after the surgery	Postoperative delirium will be determined by CAM at 3rd postoperative day
Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)	At 3rd day after the surgery	vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested
Preoperative cognitive function	Preoperative cognitive function (baseline)	Preoperative cognitive function will be assessed by neuropsychological battery
Postoperative cognitive dysfunction	Change from baseline cognitive dysfunction at 3rd month	Postoperative cognitive dysfunction will be assessed by neuropsychological battery
Retinal nerve fiber layer thickness	Change from baseline RNFL thickness at 3rd month	Retinal nerve fiberlayer（RNFL）thickness will be measured by optical coherence tomography (OCT) before and after surgery and anesthesia

Trial Locations

Locations (1)

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, Shanghai, China