Postspinal Headache and Near Infrared Spectroscopy (NIRS) | NCT04187846

Studies
Postspinal Headache and Near Infrared Spectroscopy (NIRS)

NCT04187846

Sponsor

Hakan Tapar

Status

Unknown status

Last Update Posted

Dec 5, 2019Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Tissue Oxygenation

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2019Actual

Primary Completion Date

Dec 30, 2019Estimated

Completion Date

Mar 10, 2020Estimated

First Submitted Date

Dec 2, 2019

First Submission Date that Met QC Criteria

Dec 4, 2019

First Posted Date

Dec 5, 2019Actual

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

Dec 4, 2019

Last Update Posted Date

Dec 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Evaluation of the relationship between postspinal headache and near infrared spectroscopy in cesarean section patients

Detailed Description

Patients with cesarean section under spinal anesthesia were included in the study. Before the study, patients were moniterized with NIRS device in the preoperative waiting room.NIRS moniterization was continued intraoperatively at 1st, 4th, 7th, 10th, 15th, 30th minutes and 24th postoperative period.

Patients were divided into two groups as those with postspinal headache (Group A) and those with postspinal headache (Group B). In this study, NIRS values between two groups were compared.

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Near Infrared spectroscopy	Tissue oxygenation	Up to 20 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective cesarean section

Exclusion Criteria:

Not willing to participate in the study
Use of anti-psychotic or anti-depressant drugs
Patients with headaches

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Patients with cesarean section under spinal anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hakan Tapar	Contact	+905056844496		hakantapar@hotmail.com

Overall Officials

Name	Affiliation	Role
Hakan Tapar	Gaziosmanpasa University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziosmanpasa University	Recruiting	Tokat Province		60200	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D051299	Post-Dural Puncture Headache

Ancestor Terms

ID	Term
D051271	Headache Disorders, Secondary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided