Desflurane Potentially Induces Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Perioperative Procedures by Modulating Cdc42 and Clock Proteins

NCT06772558 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2024-MER-322
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Avascular Necrosis of the Femoral Head; Coronary Artery Disease (CAD); Benign Prostatic Hyperplasia (BPH); Cholecystitis; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline (before therapy), at 2 days post-treatment

Secondary Outcomes (1)

• Cell division control protein 42 homolog (Cdc42) and Circadian Locomotor Output Cycles Kaput(Clock)

  At baseline (before therapy), at 2 days post-treatment

Study Arms (2)

POCD group

EXPERIMENTAL

Postoperative cognitive dysfunction group

Drug: Desflurane Inhalation; Device: mechanical ventilation (MV)

Control

ACTIVE COMPARATOR

No postoperative cognitive dysfunction group

Drug: Desflurane Inhalation; Device: mechanical ventilation (MV)

Interventions

Desflurane Inhalation DRUG

Anesthesia was maintained with either desflurane, with inhaled concentrations adjusted based on electroencephalogram (EEG) monitoring.

Control; POCD group

mechanical ventilation (MV) DEVICE

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%.

Control; POCD group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> 70 years
• American Society of Anesthesiologists (ASA) physical status classification I-III
• Scheduled to undergo elective surgery requiring general anesthesia with desflurane
• Able and willing to provide voluntary written informed consent
• Able to understand the study procedures and complete follow-up assessments

You may not qualify if:

• Pre-existing diagnosis of dementia or any other neurodegenerative disease that could affect cognitive function
• Preoperative Montreal Cognitive Assessment (MoCA) score \< 20
• History of severe psychiatric disorders, including psychosis, severe depression, or bipolar disorder
• Unstable angina, uncontrolled hypertension, or a history of myocardial infarction within the past 6 months
• Severe chronic obstructive pulmonary disease (COPD) with significant respiratory compromise, or other significant respiratory disease
• Severe hepatic or renal impairment, defined as Child-Pugh class C for liver disease, or glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2 for kidney disease
• History of stroke, transient ischemic attack (TIA), or other significant neurological disorders
• History of alcohol or drug abuse
• Patients with visual, auditory, or language impairments that would interfere with cognitive testing.
• Known allergy or contraindication to any of the study drugs
• Other conditions at the discretion of the investigator that could interfere with the conduct of the study or the interpretation of the results

Sponsors & Collaborators

• Xiaguang Duan: lead

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

MeSH Terms

Conditions

Femur Head Necrosis; Coronary Artery Disease; Prostatic Hyperplasia; Cholecystitis; Osteoarthritis, Knee

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Central Study Contacts

Xiaguang Associate Professor, Master's degree

CONTACT

+86 13314720012; alonlord2023@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of Anesthesiology

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 10, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

CN (1)