NCT05793437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

March 3, 2023

Last Update Submit

January 31, 2024

Conditions

Hypercapnia

Keywords

Neurofilament lightHypercapnia

Outcome Measures

Primary Outcomes (1)

  • Changes in plasma Neurofilament Light levels

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

    1 week

Study Arms (2)

permissive hypercapnia

EXPERIMENTAL

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

Behavioral: permissive hypercapnia

normocapnia

ACTIVE COMPARATOR

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

Behavioral: normocapnia

Interventions

permissive hypercapniaBEHAVIORAL

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

Also known as: PaCO2:45～55mmHg
permissive hypercapnia
normocapniaBEHAVIORAL

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

Also known as: PaCO2:35～45mmHg
normocapnia

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, 314000, China

Location

MeSH Terms

Conditions

HypercapniaCharcot-Marie-Tooth disease, Type 1F

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Qinghe Zhou

    Affiliated Hospital of Jiaxing University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 31, 2023

Study Start

April 1, 2023

Primary Completion

January 28, 2024

Study Completion

January 28, 2024

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)