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Effects of Mild Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light

Sponsor
Affiliated Hospital of Jiaxing University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05793437
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
26
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to conduct a prospective, single-center randomized controlled study to investigate the changes of plasma NFL concentration in patients undergoing laparoscopic surgery with mild hypercapnia, and further explore its impact on the central nervous system.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: mild hypercapnia
  • Behavioral: normocapnia
 N/A

Detailed Description

Plasma NFL concentrations were measured preoperatively and 1 day postoperatively.

Secondary endpoints:MMSE (Mini-Mental State Exam) and CAM (Confusion Assessment Method) is conducted to check the subjects' baseline cognitive function preoperative day and 0 to 7 postoperative day twice a day to assess whether delirium occurs.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Single
Primary Purpose:
Treatment
Official Title:
Effects of Mild Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light in Patients Undergoing Laparoscopic Surgery:A Prospective, Randomized Controlled Study
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: mild hypercapnia

Tidal volume (6-8ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:46～55mmHg

Behavioral: mild hypercapnia
Tidal volume (6-8ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:46～55mmHg
Other Names:
  • PaCO2:46～55mmHg

    		•
    Active Comparator: normocapnia

    Tidal volume (8-10ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:35～45mmHg

    Behavioral: normocapnia
    Tidal volume (8-10ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:35～45mmHg
    Other Names:
  • PaCO2:35～45mmHg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in plasma Neurofilament Light levels [1 year]

      Comparison of changes in plasma Neurofilament Light levels pre and postoperative in patients exposed and not exposed to hypercapnia.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age over 18 years

    • surgery of greater than 60 min

    • American Society of Anesthesiology (ASA) status Ⅰ-Ⅲ

    • undergoing laparoscopic surgery under general anesthesia with endotracheal intubation

    Exclusion Criteria:

    • history of mental or neurological disorders

    • preoperative use of antipsychotic drugs

    • American Society of Anesthesiology (ASA) status Ⅳ

    • severe abnormalities in heart, lung, liver, kidney, and coagulation function

    • Intracranial space-occupying lesions or major cerebrovascular diseases (such as carotid atherosclerosis and cerebral aneurysm)

    • Severe hypertension or hypotension

    • Severe metabolic acidosis or hypercapnic respiratory failure before surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Affiliated Hospital of Jiaxing University Jiaxing Zhejiang China 314000

    Sponsors and Collaborators

    • Affiliated Hospital of Jiaxing University

    Investigators

    • Principal Investigator: Qinghe Zhou, Affiliated Hospital of Jiaxing University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qing-he Zhou, Principal investigator, Affiliated Hospital of Jiaxing University
    ClinicalTrials.gov Identifier:
    NCT05793437
    Other Study ID Numbers:
    • 2023-KY-050
    First Posted:
    Mar 31, 2023
    Last Update Posted:
    Apr 5, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Qing-he Zhou, Principal investigator, Affiliated Hospital of Jiaxing University
    Neurofilament light
    Hypercapnia
    Additional relevant MeSH terms:
    Hypercapnia

    Study Results

    No Results Posted as of Apr 5, 2023