LINC01844 as a Diagnostic Biomarker for POCD in Elderly Patients

NCT06387836 | Completed

• 1 other identifier: B2024-063
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative cognitive dysfunction (POCD) is a common complication after surgery that is associated with more adverse events and death. The goal of this randomized, controlled clinical study is to learn about the impact of different inhalation anesthetics may have on the elderly in terms of POCD and diagnosis performance of long intergenic non-coding RNA(LINC01844) level in blood of older people for POCD. The main question it aims to answer is: Dose the desflurane have less influence on the elderly's cognitive function in comparison with isoflurane？Does the relative level of LINC01844 in blood help diagnose POCD of older people after surgery? Participants undergoing elective lumbar decompression and fusion will finish neuropsychological evaluations one day before and 1st, 3rd and 5th day after surgery. At the same timepoint, the relative level of LINC01844 in blood will also be tested.

Conditions

Postoperative Cognitive Dysfunction

Keywords

postoperative cognitive dysfunction; long intergenic non-coding RNA; prediction biomarker

Outcome Measures

Primary Outcomes (1)

• incidence of POCD

  The incidence of POCD is defined as the proportion of people who is diagnosed POCD at least once of the three times(on postoperative day 1, day 3 and day 5) in this group. POCD is diagnosed using the Z-score method. Patients were tested with a battery of 7 neurocognitive tests, and POCD was considered when the Z-score \> 1.961in two or more tests .

  From date of randomization until the date of telephone follow-up completed , assessed up to 2 months.

Secondary Outcomes (3)

• serum reactive protein-C

  From date of randomization until the date of discharge , assessed up to 10 days.

• serum interleukin-6

  From date of randomization until the date of discharge , assessed up to 10 days.

• relative level of LINC01844

  From date of randomization until the date of discharge , assessed up to 10 days.

Study Arms (2)

Iso anesthesia

ACTIVE COMPARATOR

Patients in this group are under anesthesia with isoflurane.

Drug: Isoflurane 0.8 MAC

Des anesthesia

ACTIVE COMPARATOR

Patients in this group are under anesthesia with desflurane.

Drug: Desflurane 0.8MAC

Interventions

Isoflurane 0.8 MAC DRUG

Patients in this group will be anesthetized using isoflurane with the depth of 0.8\~1.0MAC during the operation.

Iso anesthesia

Desflurane 0.8MAC DRUG

Patients in this group will be anesthetized using desflurane with the depth of 0.8\~1.0MAC during the operation.

Des anesthesia

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients scheduled to perform elective lumbar decompression and interbody fusion under general anesthesia;
• years old;
• American Society of Anesthesiologists (ASA) physical status I-III level;
• Body mass index (BMI) between 20 Kg/m2 and 28 Kg/m2;
• From whom written informed consent is obtainable either from the patient or from a legal representative;

You may not qualify if:

• Patents with cognitive dysfunction preoperatively;
• Patents with verbal, visual and auditory defects;
• Patients with history of alcohol and/or drug abuse, or history of neurological and psychotic disorders;
• Patients with history of hospital admission and therapy within 30 days.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (18)

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  PMID: 41366726 DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Shengjin Ge, Ph.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 29, 2024
• Study Start: April 23, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)