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NCT03918889
Effect of Dexmedetomidine in Preventing Cough and Postoperative Pain After Laryngeal Surgery for Cancer
NA trial testing Dexmedetomidine Injectable Product in Laryngectomy; Status in 120 participants. Status unknown.
1 December 2020
Quick facts
| Lead sponsor | Eye & ENT Hospital of Fudan University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 1 May 2019 |
| Primary completion | 1 December 2020 |
| Estimated completion | 1 December 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Dexmedetomidine Injectable Product — full drug profile →
- Midazolam injection — full drug profile →
Conditions studied
- Laryngectomy; Status — all drugs for Laryngectomy; Status →
Sponsor
Eye & ENT Hospital of Fudan University
Who can join
Adults 35 to 65, male only, with Laryngectomy; Status. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: During emergence from anesthesia for partial and total laryngectomy, severe airway reflex and systemic hypertension during recovery may lead to pneumoderm, hemorrhage, pneumomediastinum or pneumothorax. Dexmedetomidine is a selective α2-adrenoreceptor agonist that has sedative, analgesic, and sympatholytic properties. It has been reported dexmedetomidine can attenuate coughing reflex and prevent emergence agitation without delaying recovery and respiratory depression from general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine compared with midazolam on cough suppression and recovery quality during emergence from general anesthesia after partial and total laryngectomy. Methods American Society of Anesthesiologists physical status I-II male adults undergoing elective laryngectomy under sevoflurane anesthesia were recruiting and randomly allocated to receive either dexmedetomidine(Group D, n = 60) infusion at 0.5 µg•kg-1 for 10 min before tracheotomy, then adjusted to 0.3µg•kg-1•h-1 or midazolam (Group M, n = 60) infusion at 0.05 mg•kg-1 ten minutes before tracheotomy, then adjusted to 0.02mg•kg-1•h-1. The primary outcome measure was the incidence and severity of cough. Hemodynamics, pain intensity \[Visual Analogue Scale (VAS)\] and Ramsay sedation scale (RSS) were also evaluated at awake, patients returning to ward from post anesthesia care unit (PACU),2h after surgery. postoperative sufentanil consumption, recovery time and the incidence of concerning adverse effects were recorded.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Dexmedetomidine versus midazolam on cough and recovery quality after partial and total laryngectomy - a randomized controlled trial.
Xu R, Zhu Y, Lu Y, Li W, et al · · 2020 · cited 5× · PMID 32988369 · DOI 10.1186/s12871-020-01168-7
Verify or expand the search:
- PubMed search for NCT03918889
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Laryngectomy; Status
Currently open trials in the same condition.
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Other Eye & ENT Hospital of Fudan University 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 NCT03918889 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eye & ENT Hospital of Fudan University
- Last refreshed: 18 January 2020
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/NCT03918889.
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