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NCT Number: NCT05793437

Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light

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.

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Key information

Conditions

Hypercapnia Charcot-Marie-Tooth disease, Type 1F Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, 314000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

permissive hypercapnia

Behavioral

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

Other names: PaCO2:45～55mmHg

normocapnia

Behavioral

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

Other names: PaCO2:35～45mmHg

Primary outcomes

  1. Changes in plasma Neurofilament Light levels

    Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Jiaxing University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2023
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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