Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05793437

Enrollment

Registered

2023-03-31

Start date

2023-04-01

Completion date

2024-01-28

Last updated

2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercapnia

Keywords

Neurofilament light, Hypercapnia

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.

Interventions

BEHAVIORALpermissive hypercapnia

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

BEHAVIORALnormocapnia

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Single

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026