Dysphagia After Anterior Cervical Decompression and Fusion of the Spine
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled study to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients.
Detailed description
The purpose of this randomized, double-blind, placebo-controlled study is to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients. This study aims to investigate if there is a difference in the efficacy of intravenous steroids compared to a placebo of physiological saline for patients undergoing anterior cervical spine surgery. Furthermore, this study aims to investigate the correlation between radiographic measurements of soft tissue swelling and the severity of dysphagia for patients. Finally, this study aims to examine the impact of intravenous steroids on nausea and radicular pain in patients. Secondary outcome measures will include patient focused outcomes questionnaires, pain medication requirements, and fusion rates.
Interventions
DRUGDexamethasone
The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
OTHERSaline
The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The subjects included in the study are patients undergoing an anterior cervical spine procedure.
Exclusion criteria
* Patients with greater than ASA grade II will be excluded. Patients with non-degenerative conditions, such as trauma, tumors, infection, radiation, and diabetes will be excluded. Patients with posterior procedures will be excluded. Patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on the EAT-10 questionnaire,19 will also be excluded. Patients who are pregnant will be excluded from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intravenous Corticosteroids Effect on Post-operative Dysphagia | 12 months | The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia. |
| The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients. | 12 months | Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery. | 12 months | Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration. |
| Examine the Impact of Dexamethasone on the Development of Postoperative Nausea. | Immediate post-operatively | This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery. |
| Examine the Impact of Dexamethasone on Radicular Pain. | 12 months | This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain. |
| Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates. | 12 months | The outcomes of surgery will be examined through the 1 year post-operative appointment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose. | 1 |
| Saline Subject will receive doses of intravenous physiological saline solution.
Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. | 3 |
| Total | 4 |
Baseline characteristics
| Characteristic | Dexamethasone | Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Region of Enrollment United States | 1 participants | 3 participants | 4 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 |
Outcome results
Primary
Intravenous Corticosteroids Effect on Post-operative Dysphagia
The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia.
Time frame: 12 months
Population: Data not available due to premature halting of study
Primary
The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients.
Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary.
Time frame: 12 months
Population: Data not available due to premature halting of study
Secondary
Examine the Impact of Dexamethasone on Radicular Pain.
This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain.
Time frame: 12 months
Population: Data not available due to premature halting of study
Secondary
Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.
This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery.
Time frame: Immediate post-operatively
Population: Data not available due to premature halting of study
Secondary
Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.
The outcomes of surgery will be examined through the 1 year post-operative appointment.
Time frame: 12 months
Population: Data not available due to premature halting of study
Secondary
The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.
Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration.
Time frame: 12 months
Population: Data not available due to premature halting of study