Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light

Affiliated Hospital of Jiaxing University

Status: Completed

Conditions: Hypercapnia

Treatments: Behavioral: normocapnia; Behavioral: permissive hypercapnia

Study type: Interventional

Funder types: Other

Identifiers

NCT05793437

2023-KY-050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

permissive hypercapnia

Experimental group

Description:

Tidal volume (6-8ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:45～55mmHg

Treatment:

Behavioral: permissive hypercapnia

normocapnia

Active Comparator group

Description:

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

Treatment:

Behavioral: normocapnia