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

January 12, 2025 updated by: Xiaguang Duan

The Potential Mechanism by Which Desflurane Induces Postoperative Cognitive Dysfunction in Elderly Perioperative Patients Involves the Modulation of Cdc42 and Clock Proteins, and Their Related Signaling Pathways.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaguang Associate Professor, Master's degree
  • Phone Number: +86 13314720012
  • Email: alonlord2023@gmail.com

Study Locations

  • China
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • Inner Mongolia Baogang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POCD group
Postoperative cognitive dysfunction group
Drug: Desflurane Inhalation
Anesthesia was maintained with either desflurane, with inhaled concentrations adjusted based on electroencephalogram (EEG) monitoring.
Device: mechanical ventilation (MV)
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%.
Active Comparator: Control
No postoperative cognitive dysfunction group
Drug: Desflurane Inhalation
Anesthesia was maintained with either desflurane, with inhaled concentrations adjusted based on electroencephalogram (EEG) monitoring.
Device: mechanical ventilation (MV)
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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA)
Time Frame: At baseline (before therapy), at 2 days post-treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cell division control protein 42 homolog (Cdc42) and Circadian Locomotor Output Cycles Kaput(Clock)
Time Frame: At baseline (before therapy), at 2 days post-treatment
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.
At baseline (before therapy), at 2 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaguang Duan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 10, 2025

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 12, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-MER-322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

January 2026-January 2036

IPD Sharing Access Criteria

A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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