Comparative study of intraoperative bleeding severity measuring by utilizing Validated Intraoperative Bleeding Scales for lumbar spine surgery

Comparative study of intraoperative bleeding severity measuring by utilizing Validated Intraoperative Bleeding Scales for lumbar spine surgery: Controlled hypotensive anesthesia vs Normotensive anesthesia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006539

Enrollment

Registered

2021-09-03

Start date

2021-08-11

Completion date

Unknown

Last updated

2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(surgical hemostasis) : - It is intended for patients with degenerative lumbar disease over the age of 50 -The surgery will be carried out including mid-line incision and facetectomy, which are

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -patients with degenerative lumbar disease aged 50 to 70 years -Patient scheduled for lumbar spine surgery including decompressive surgery (decompressive laminectomy, discectomy etc.) and fusion procedures.

Exclusion criteria

Exclusion criteria: 1. patients who did not consent to the study 2. the case that anesthesiologist does not select hypotensive anesthesia as the standard of care 3. Patients who could not read or understand the consent documents 4. Patients scheduled 2 stage operation and long-segment fusion operation in the abnormal thoracic spine 5. Patients who are trauma and Infection 6. Patients who are malignancy tumor and metastasis 7. Patients who are contraindicated for hypotensive anesthetic surgery and Ischemic cardiovascular disease - Patients who cannot discontinue antithrombotic or antiplatelet medications prior to surgery - coronary artery disease and echocardiographic EF 40% stenosis) and cerebrovascular disease( stroke, transient ischemic attack, brain tumor, syncope) 9. Diabetes and renal failure(estimated Glomerular Filtration Rate less than 60 ml/min/1.73m2

Design outcomes

Primary

Measure	Time frame
VIBe sales will be utilized to measure the bleeding intensity at bleeding site prior to applicate adequate hemostasis method.	—

Secondary

Measure	Time frame
The period before drainage tube removal;drainage amount in drain bag during surgery;cumulative drainage amount in drain bag;decrease of bleeding grade to lower grade after application of hemostatic agents	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Ho Lee

Yonsei University Health System, Severance Hospital

bhlee96@yuhs.ac+82-2-2228-2193

Outcome results