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NCT05793437 Clinical Trial

Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light

Hypercapnia Clinical Trial

Official title:
Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light in Elderly Patients Undergoing Laparoscopic Surgery:A Prospective, Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05793437
Other study ID # 2023-KY-050
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date January 28, 2024

Study information
Verified date January 2024
Source Affiliated Hospital of Jiaxing University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Plasma NFL concentrations were measured preoperatively and 1 day postoperatively. Secondary endpoints:CAM (Confusion Assessment Method) is conducted to check the subjects' baseline cognitive function preoperative day and 1 day postoperatively to assess whether delirium occurs.

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date January 28, 2024
Est. primary completion date January 28, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - age over 60 years - duration of pneumoperitoneum greater than 60 minutes - American Society of Anesthesiology (ASA) status ?-? - 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 ? - 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• permissive hypercapnia
Tidal volume (6-8ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:45~55mmHg
• normocapnia
Tidal volume (8-10ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:35~45mmHg

Locations
Country Name City State
China Affiliated Hospital of Jiaxing University Jiaxing Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Affiliated Hospital of Jiaxing University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in plasma Neurofilament Light levels Comparison of changes in plasma Neurofilament Light levels pre and postoperative in patients exposed and not exposed to hypercapnia. 1 week
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