Effect of preoperative systemic dexamethasone on postoperative dysphagia following anterior cervical spine surgery A prospective randomize, double-blinded, controlled trial study

Phase 4

Completed

• Conditions: determine the effect of intravenous dexamethasone administered prior to the anterior cervical discectomy and fusion (ACDF) operation via clinical data and plain radiographic data, whether it can reduce prevertebral soft tissue swelling (PSTS) and the symptoms of dysphagia.; ACDF; Dexamethasone; dysphagia

• Registration Number: TCTR20210716004
• Lead Sponsor: /A

Brief Summary

A group of patients being administered with intravenous dexamethasone compared with the placebo group, demonstrated significant decrease in the severity of dysphagia during 72-hour postoperative period. This is proved through the modified JOA score to be significantly lower at two weeks follow-up after the surgery in the group using steroid than in the saline group

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-01-01
• Study Start: 2021-07-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1.Age older than 18 years
2.Patients requiring anterior cervical discectomy and fusion for 1-2 levels at Thammasat Hospital
3.Patients who signed a written informed consent after being informed about the purpose and detail of the study

Exclusion Criteria

1.Patients who underwent revision surgery
2.Regular usage of steroids
3.Allergic or contraindicated to steroid use
4.Pregnancy
5.Uncontrolled diabetes mellitus

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
dysphagia 2 weeks Bazaz's dysphagia questionnaire ,Odynophagia 2 weeks VAS

Secondary Outcome Measures

Name	Time	Method
Prevertebral soft-tissue swelling ratio(S/V) 2 weeks Prevertebral soft-tissue swelling ratio(S/V) ,Prevertebral soft-tissue swelling index(average value of Prevertebral soft-tissue swelling ratio of C3-C5) 2 weeks Prevertebral soft-tissue swelling index(average value of Prevertebral soft-tissue swelling ratio of C3-C5) ,Japanese Orthopaedic Association score 2 weeks Japanese Orthopaedic Association score,Neck Disability Index 2 weeks Neck Disability Index