Postspinal Headache and Near Infrared Spectroscopy (NIRS)

Tissue Oxygenation Clinical Trial

Official title:

Evaluation of the Relationship Between Postspinal Headache and Near Infrared Spectroscopy in Cesarean Section Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04187846
• Other study ID #: 18-KAEK-167
• Status: Recruiting
• Start date: March 15, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: December 2019
• Source: Tokat Gaziosmanpasa University
• Contact: Hakan Tapar
• Phone: +905056844496
• Email: hakantapar[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 10, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Tissue Oxygenation

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Hakan Tapar

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near Infrared spectroscopy	Tissue oxygenation	Up to 20 weeks