Who is sponsoring NCT03760809?

NCT03760809 is sponsored by Eye & ENT Hospital of Fudan University.

What drugs are being tested in NCT03760809?

Interventions in NCT03760809: Dexmedetomidine 0.5μg／kg, Dexmedetomidine 1μg／kg.

What condition does NCT03760809 study?

NCT03760809 studies Agitated; State, Acute Reaction to Stress.

Is NCT03760809 still recruiting?

NCT03760809 is currently completed. Last updated 22 June 2021.

Last reviewed 2021-06-22 · How we verify

NCT03760809

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy

Completed Phase 4 Last updated 22 June 2021

What this trial tests

Phase 4 trial testing Dexmedetomidine 0.5μg／kg in Agitated; State, Acute Reaction to Stress in 130 participants. Completed in 1 April 2019.

Timeline

4 January 2019

Primary endpoint
10 February 2019

1 April 2019

Quick facts

Lead sponsor	Eye & ENT Hospital of Fudan University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	130
Start date	4 January 2019
Primary completion	10 February 2019
Estimated completion	1 April 2019
Sites	1 location across China

Drugs / interventions tested

Dexmedetomidine 0.5μg／kg — full drug profile →
Dexmedetomidine 1μg／kg — full drug profile →

Conditions studied

Agitated; State, Acute Reaction to Stress — all drugs for Agitated; State, Acute Reaction to Stress →

Sponsor

Eye & ENT Hospital of Fudan University

Who can join

Adults 3 to 10, any sex, with Agitated; State, Acute Reaction to Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tonsillectomy and adenoidectomy is one of the most common pediatric surgeries, and agitation and severe postoperative pain have been considered a very common complications. Dexmedetomidine mainly inhibits the release of norepinephrine by acting on the α-adrenergic receptor of the brainstem nucleus, which can produce good sedative effects. Hydromorphone has a longer duration of action than fentanyl, and it also has a certain sedative effect. The combination of the two is more conducive to the management of postanesthetic agitation and pain. This study was to compare the effect of different doses of dexmedetomidine combined with hydromorphone in the sedation and analgesia after pediatric tonsillectomy and adenoidectomy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The effect of two different doses of dexmedetomidine to prevent emergence agitation in children undergoing adenotonsillectomy: a randomized controlled trial.
Yi W, Li J, Zhuang Y, Wan L, et al · · 2022 · cited 3× · PMID 34627829 · DOI 10.1016/j.bjane.2021.08.019

Verify or expand the search:

Other Eye & ENT Hospital of Fudan University trials

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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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03760809 (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: 22 June 2021

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/NCT03760809.

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