The Role of Cognitive Function and Electroencephalography... | NCT03761576

Studies
The Role of Cognitive Function and Electroencephalography on Acute and Chronic Pain After Surgery

NCT03761576

Sponsor

Yi Feng, MD

Status

Unknown status

Last Update Posted

Oct 18, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Acute Pain
Chronic Pain
Thoracic Surgery
Electroencephalography
Brain Mechanism

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 21, 2018Actual

Primary Completion Date

Mar 31, 2021Actual

Completion Date

Oct 31, 2023Estimated

First Submitted Date

Nov 30, 2018

First Submission Date that Met QC Criteria

Nov 30, 2018

First Posted Date

Dec 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2022

Last Update Posted Date

Oct 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yi Feng, MD, director of department of anesthesiology and painmanagement, Peking University People's HospitalSponsor-Investigator

Lead Sponsor

Yi Feng, MDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The project will apply the methods of clinical observation experiment, (1) to collect the cognitive function data preoperatively and early postoperatively, as well as the pain score data at multiple time points pre- and postoperatively, and to observe the role of the degree of recovery of early postoperative cognitive function on acute pain and chronic pain after surgery. (2) to collect the resting-state electroencephalography (EEG) preoperatively, and to assess the role of EEG index system on the prediction of the degree of recovery of early postoperative cognitive function as well as the acute pain and chronic pain after surgery.

Detailed Description

Patients after surgery are liable to suffer from moderate to severe acute pain and refractory chronic pain, which would lead to serious somatic and psychological suffering. Its successful treatment is a great challenge for pain physicians. To date, the mechanism of pain chronification after surgery remains unclear. Further, it is still lack of efficient preventive and therapeutic measures for this chronic pain. The project will apply the methods of clinical observation and animal experiment, (1) to collect the cognitive function data preoperatively and early postoperatively, as well as the pain score data at multiple time points pre- and postoperatively, and to observe the role of the degree of recovery of early postoperative cognitive function on acute pain and chronic pain after thoracic surgery. (2) to collect the resting-state electroencephalography (EEG) preoperatively, and to assess the role of EEG index system on the prediction of the degree of recovery of early postoperative cognitive function as well as the acute pain and chronic pain after thoracic surgery. The project will be able to determine the relationships between the degree of recovery of early postoperative cognitive function, as well as preoperative resting-state EEG indices and postoperative acute pain and chronic pain, and clarify the neural mechanism of acute pain and chronic pain after surgery. The expected outcomes of this study can contribute to early identification of the patients who are liable to develop into acute pain and chronic pain after surgery, and give them reasonable intervention in time, and provide effective solutions for the acute pain and chronic pain after surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
acute pain	numerical rating scale(NRS)>3	the third day of the surgery
chronic pain	numerical rating scale(NRS)>3	the second month of the surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

surgery were planned to be performed under general anesthesia
Educational attainment beyond high school
Require postoperative analgesia and sign the informed consent

Exclusion Criteria:

with mental illness or a family history of mental illness
Patients with cerebrovascular diseases or cerebrovascular accidents
Previous head trauma history or craniotomy
Using central analgesics, opioids addiction
With a history of alcoholism
do not understand the numerical rating scale(NRS) score and can not use patient-controlled analgesia(PCA）

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

100

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yi Feng, MD	Peking University People's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's Hospital		Beijing	Beijing Municipality	100044	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41087907	Derived	Zhang YQ, Li YR, Han Q, Gao F, Feng Y. Evaluation of dynamic brain function in patients with different degrees of chronic pain by EEG microstate analysis. BMC Anesthesiol. 2025 Oct 14;25(1):491. doi: 10.1186/s12871-025-03326-1.
33897775	Derived	Han Q, Yue L, Gao F, Zhang L, Hu L, Feng Y. The Prediction of Acute Postoperative Pain Based on Neural Oscillations Measured before the Surgery. Neural Plast. 2021 Apr 9;2021:5543974. doi: 10.1155/2021/5543974. eCollection 2021.

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms