Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light

NCT ID: NCT05793437

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-01-28

Brief Summary

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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

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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.

Conditions

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Hypercapnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Single

Study Groups

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permissive hypercapnia

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

Group Type EXPERIMENTAL

permissive hypercapnia

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

normocapnia

Intervention Type BEHAVIORAL

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

Interventions

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permissive hypercapnia

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

Intervention Type BEHAVIORAL

normocapnia

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

Intervention Type BEHAVIORAL

Other Intervention Names

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PaCO2:45~55mmHg PaCO2:35~45mmHg

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role lead

Responsible Party

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Qing-he Zhou

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qinghe Zhou

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Jiaxing University

Locations

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Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2023-KY-050

Identifier Type: -

Identifier Source: org_study_id

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