Study of Post-anesthesia Management in Patients Undergoin... | NCT04362709

Studies
Study of Post-anesthesia Management in Patients Undergoing Neurosurgery

NCT04362709

Sponsor

Beijing Tiantan Hospital

Status

Recruiting

Last Update Posted

Jul 18, 2025Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Anesthesia
Neurosurgery
Complication

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

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2019Actual

Primary Completion Date

Nov 22, 2028Estimated

Completion Date

Nov 22, 2028Estimated

First Submitted Date

Jan 14, 2020

First Submission Date that Met QC Criteria

Apr 22, 2020

First Posted Date

Apr 27, 2020Actual

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

Jul 17, 2025

Last Update Posted Date

Jul 18, 2025Actual

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 postoperative complications of neurosurgery are various and complex, which brings heavy economic and social burden to families. Timely detection and early intervention can help reduce the incidence of adverse events and mortality. The main purpose of this study is to analyze the possible factors related to postoperative complications of Neurosurgery, so as to achieve the prospective prevention and treatment of postoperative complications of neurosurgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of postoperative complications in neurosurgery.	The incidence of postoperative complications was diagnosed by the corresponding assessment scale.Complications include nausea, vomiting, delirium, delayed recovery, intracranial hematoma,etc.	5±2 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients received neurosurgery in Beijing Tiantan hospital.

Exclusion Criteria:

Preoperative severe cognitive dysfunction ；
Refused to sign informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients expected to returned to post-anesthesia care unit(PACU) after neurosurgical treatment in Beijing Tiantan hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuming Peng, M.D., Ph.D	Contact	8610-59976658		florapym766@163.com

Overall Officials

Name	Affiliation	Role
Yuming Peng, M.D., Ph.D	Department of Anesthesiology, Beijing Tiantan Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing TianTan Hospital	Recruiting	Beijing		100070	China

Label	Type	Description	Intervention Names
Postoperative complications
No postoperative complications