Back to resultsEffects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light
Primary Purpose
Hypercapnia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
permissive hypercapnia
normocapnia
Sponsored by
About this trial
This is an interventional treatment trial for Hypercapnia focused on measuring Neurofilament light, Hypercapnia
Eligibility Criteria
Inclusion Criteria: age over 60 years surgery of greater than 90 min 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
Sites / Locations
- Affiliated Hospital of Jiaxing UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
permissive hypercapnia
normocapnia
Arm Description
Tidal volume (6-8ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2≥46 mmHg
Tidal volume (8-10ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:35～45mmHg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05793437
First Posted
March 3, 2023
Last Updated
October 16, 2023
Sponsor
Affiliated Hospital of Jiaxing University
1. Study Identification
Unique Protocol Identification Number
NCT05793437
Brief Title
Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light
Official Title
Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light in Elderly Patients Undergoing Laparoscopic Surgery:A Prospective, Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Jiaxing University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:MMSE (Mini-Mental State Exam) and CAM (Confusion Assessment Method) is conducted to check the subjects' baseline cognitive function preoperative day and 0 to 7 postoperative day twice a day to assess whether delirium occurs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnia
Keywords
Neurofilament light, Hypercapnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
permissive hypercapnia
Arm Type
Experimental
Arm Description
Tidal volume (6-8ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2≥46 mmHg
Arm Title
normocapnia
Arm Type
Active Comparator
Arm Description
Tidal volume (8-10ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:35～45mmHg
Intervention Type
Behavioral
Intervention Name(s)
permissive hypercapnia
Other Intervention Name(s)
PaCO2≥46 mmHg
Intervention Description
Tidal volume (6-8ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2≥46 mmHg
Intervention Type
Behavioral
Intervention Name(s)
normocapnia
Other Intervention Name(s)
PaCO2:35～45mmHg
Intervention Description
Tidal volume (8-10ml/kg) and respiratory rate is adjusted to achieve the objective values of PaCO2:35～45mmHg
Primary Outcome Measure Information:
Title
Changes in plasma Neurofilament Light levels
Description
Comparison of changes in plasma Neurofilament Light levels pre and postoperative in patients exposed and not exposed to hypercapnia.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age over 60 years
surgery of greater than 90 min
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qinghe Zhou
Phone
+8613732573379
Email
jxxmxy@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yazhi Xi
Phone
+8615536368031
Email
xiyazhi1996@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qinghe Zhou
Organizational Affiliation
Affiliated Hospital of Jiaxing University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Jiaxing University
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinghe Zhou
Phone
+8613732573379
Email
jxxmxy@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light
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