Clinical trial

Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control Trial

Name

KSKC20222025

Description

Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects, aiming to enhance the effectiveness of surgery and improve patient outcomes.

Trial arms

Trial start

2024-05-01

Estimated PCD

2025-04-30

Trial end

2025-05-31

Status

Not yet recruiting

Phase

Early phase I

Treatment

Dexamethasone

long-acting corticosteroid IV route

Arms:

Dexamethasone group

Normal saline

normal saline

Arms:

Normal saline group

Size

Primary endpoint

effectiveness of dexamethasone

24 hours, 2 weeks, 6 weeks, 12 weeks post operative period

Eligibility criteria

Inclusion Criteria: * Age range: 50-80 years old. * Undergoing MIS TLIF surgery at 1-2 spinal levels. Exclusion Criteria: * Previously undergone spine surgery. * HbA1C greater than or equal to 7.5 mg% * Allergic to all types of experimental medication. * History of using systemic steroids.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-04-16

1 organization

2 products

5 indications

Organization

Potsawat Surabotsopon

Product

Dexamethasone

Indication

Lumbar Spinal Stenosis

Indication