Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light

Not Applicable

Completed

• Conditions: Hypercapnia
• Interventions: Behavioral: permissive hypercapnia; Behavioral: normocapnia

• Registration Number: NCT05793437
• Lead Sponsor: Affiliated Hospital of Jiaxing University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-19
• Study First Posted: 2023-03-31
• Study Start: 2023-04-01
• Status Verified: 2024-01
• Primary Completion: 2024-01-28
• Study Completion: 2024-01-28
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• age over 60 years
• duration of pneumoperitoneum greater than 60 minutes
• American Society of Anesthesiology (ASA) status Ⅱ-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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes in plasma Neurofilament Light levels	1 week	Comparison of changes in plasma Neurofilament Light levels pre and postoperative in patients exposed and not exposed to hypercapnia.

Trial Locations

Locations (1)

Affiliated Hospital of Jiaxing University; 🇨🇳 Jiaxing, Zhejiang, China