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NCT03312413: EDCSTS
Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery
Phase 4 trial testing Dexmedetomidine Hydrochloride in Anesthesia Complication in 400 participants. Status unknown.
31 August 2018
Quick facts
| Lead sponsor | Min Su |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 10 August 2017 |
| Primary completion | 31 August 2018 |
| Estimated completion | 31 December 2018 |
| Sites | 1 location across China |
Drugs / interventions tested
- Dexmedetomidine Hydrochloride — full drug profile →
- Normal Saline
- Dexmedetomidine Hydrochloride — full drug profile →
- Dexmedetomidine Hydrochloride — full drug profile →
Conditions studied
- Anesthesia Complication — all drugs for Anesthesia Complication →
Sponsor
Min Su — full company profile →
Who can join
Adults 18 to 65, any sex, with Anesthesia Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Maintenance of a remifentanil infusion during anesthetic emergence has been reported to decrease the incidence of coughing and thereby help to ensure a smooth emergence. It may, however, cause respiratory depression and possibly delay emergence. The purpose of this study was to investigate the effect of different dose of dexmedetomidine infusion on cough suppression during emergence from general anesthesia in patients undergoing thyroid surgery. American Society of Anesthesiologists physical status I-II adults undergoing elective thyroidectomy under general anesthesia are recruited and randomly allocated to receive dexmedetomidine iv infusion of 0.2μg·kg-1·h-1 (Group D1, n = 100), 0.5μg·kg-1·h-1 (Group D2, n = 100), 0.7μg·kg-1·h-1 (Group D3, n = 100) or saline (Group C, n = 100). Primary outcome is the incidence of coughing during emergence. Second outcomes include severity of coughing, which is assessed using a four-point scale; Ramsay score, Bruggrmann comfort scale score, VAS pain score are recorded. The respiratory rate (RR), heart rate (HR), and mean arterial pressure are also recorded.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03312413
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Min Su trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03312413 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Min Su
- Last refreshed: 17 October 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03312413.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing