An interventional study of Desflurane Inhalation and mechanical ventilation (MV) in Avascular Necrosis of the Femoral Head, Coronary Artery Disease (CAD) and Benign Prostatic Hyperplasia (BPH), sponsored by Xiaguang Duan. Not yet recruiting at 1 site in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Xiaguang Duan · Not applicable, Interventional, and Treatment
This clinical trial investigates whether desflurane induces postoperative cognitive dysfunction (POCD) in elderly patients undergoing perioperative procedures by modulating Cdc42 and Clock proteins. The primary research questions are: (1) Does desflurane administration contribute to POCD in this patient population? and (2) Are alterations in Cdc42 and Clock protein levels associated with desflurane-induced POCD in elderly patients? To address these questions, elderly patients will be administered desflurane for anesthesia maintenance. Postoperative assessments will then compare blood levels of Cdc42 and Clock proteins, and examine related signaling pathways, between a control group and a POCD group.
Study participants will receive desflurane anesthesia maintained at a Bispectral Index (BIS) value of 40-60. Postoperative cognitive function will be assessed on the second day using the Montreal Cognitive Assessment (MoCA), and participants will be categorized into either a control group or a POCD group based on MoCA performance. Cognitive function and blood levels of Cdc42 and Clock proteins will be recorded. Furthermore, the study will also investigate associated signaling pathways.
Study Design:
This study is a prospective, randomized, comparative, non-inferiority clinical trial with blinding of both patients and clinicians. It investigates the non-inferiority of desflurane with respect to its impact on Cdc42 and Clock protein levels following POCD in elderly patients. Patient recruitment was conducted at Baogang Hospital, Inner Mongolia. This study received approval from the Medical Ethics Committee of Baogang Hospital, Inner Mongolia, and was performed in accordance with the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) guidelines. All participants provided voluntary written informed consent.
Patients:
Sixty patients aged >70 years, with an American Society of Anesthesiologists (ASA) physical status of I-III, undergoing elective surgery requiring desflurane-based general anesthesia between February 2025 and May 2025, were recruited. Participants were randomly assigned to one of two groups (n=30 per group).
Randomization and Blinding:
Block randomization was employed to generate the random allocation sequence, with a block size of six. The random sequence was generated using dedicated software (the blockrand package in R version 4.3.2). Allocation of the sequence was performed by an independent third party, and allocation concealment was achieved using sequentially numbered, sealed, opaque envelopes. The research team was blinded to group allocation throughout the randomization process and was not involved in the generation or allocation of the random sequence.
Intervention:
Anesthesia was administered according to standardized institutional protocols. Patients received 1.5-2 mg/kg propofol, 1-2 mg/kg rocuronium, and 1-2 μg/kg remifentanil for induction. Anesthesia was maintained with either sevoflurane or desflurane, with inhaled concentrations adjusted based on electroencephalogram (EEG) monitoring. Remifentanil was continuously infused at 0.05-0.2 μg/kg/min, with adjustments made to maintain blood pressure and heart rate within ±20% of baseline values. Following induction, patients underwent mechanical ventilation in volume-controlled (VC) mode. Ventilation parameters were set using a GE Aestiva anesthesia machine (GE Healthcare, Waukesha, Wisconsin, USA): tidal volume 6-8 ml/kg, positive end-expiratory pressure 0 cmH2O, inspiration/expiration ratio 1:2, respiratory rate 16 breaths/min, and inspired oxygen concentration of 41%.
Outcomes and Measures:
Postoperative follow-up was conducted in the ward by two specially trained nurses who were blinded to patient allocation. Assessments were performed face-to-face at baseline and on the second postoperative day.
65 studies on the registry are indexed under Femur Head Necrosis; 16 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 36 interventional studies indexed under Femur Head Necrosis.
Browse Femur Head Necrosis studies →Xiaguang Duan is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postoperative cognitive dysfunction group
Drug: Desflurane Inhalation · Device: mechanical ventilation (MV)
No postoperative cognitive dysfunction group
Drug: Desflurane Inhalation · Device: mechanical ventilation (MV)
Anesthesia was maintained with either desflurane, with inhaled concentrations adjusted based on electroencephalogram (EEG) monitoring.
Following induction, patients underwent mechanical ventilation in volume-controlled (VC) mode. Ventilation parameters were set using a GE Aestiva anesthesia machine (GE Healthcare, Waukesha, Wisconsin, USA): tidal volume 6-8 ml/kg, positive end-expiratory pressure 0 cmH2O, inspiration/expiration ratio 1:2, respiratory rate 16 breaths/min, and inspired oxygen concentration of 41%.
Montreal Cognitive Assessment (MoCA)
MoCA, is a rating system from 0 to 30, where 0 represents "no postoperative cognitive dysfunction" and 30 represents the worst possible postoperative cognitive dysfunction.
Time frame: At baseline (before therapy), at 2 days post-treatment
Cell division control protein 42 homolog (Cdc42) and Circadian Locomotor Output Cycles Kaput(Clock)
The normal ranges of Cdc42 and Clock were consistent with preoperative levels. The higher the value, the greater the POCD, and the worse the outcome.
Time frame: At baseline (before therapy), at 2 days post-treatment
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: January 2026-January 2036
Access criteria: A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for May 2025, 3 months later.
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This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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