Dysphagia Clinical Trial
Official title:
The Effect of Esomeprazole Magnesium on Incidence of Dysphagia Following Anterior Cervical Spine Surgery: A Prospective, Randomized, Double Blinded, Placebo-Controlled Study
NCT number | NCT03488147 |
Other study ID # | GCO 12-1433 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 2020 |
Est. completion date | July 2, 2020 |
Verified date | November 2020 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The researchers wish to investigate whether proton pump inhibitors, administered prior to or after surgery, can reduce the incidence and/or severity of difficulty swallowing foods and/or liquids,following anterior cervical surgery.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2, 2020 |
Est. primary completion date | July 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Must be at least 18 years of age. - Scheduled to undergo anterior cervical surgery for degenerative joint disease. Exclusion Criteria: - Patients undergoing revision procedures, multi-level procedures, or procedures treating conditions other than degenerative joint disease. - Patients with preoperative dysphagia. - Patients currently taking any acid suppressing medications (proton pump inhibitors, H2 blockers, antacids, etc). - Patients who are pregnant or nursing. - Patients who, due to drug allergies, hypersensitivities/anaphylactic reactions to esomeprazole or contraindications (hypersensitivity to benzimidazoles, osteoporosis), are unable to take esomeprazole. - Patients unable to attend follow-up visits or answer the dysphagia questionnaires. Eligibility Criteria: - Scheduled to undergo anterior cervical surgery for degenerative joint disease. |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | Mount Sinai West | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dysphagia questionnaire | The Dysphagia questionnaire is a 2 item questionnaire with full scale from 0 (no swallowing difficulty) to 10 (frequent swallowing difficulty) | 12 weeks post surgery |
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