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NCT03126422

Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough

Status unknown Phase 1 Last updated 5 July 2017
What this trial tests

Phase 1 trial testing Dexmedetomidine in Fentanyl-induced Cough in 240 participants. Status unknown.

Timeline
1 May 2017
Primary endpoint
1 September 2017
1 September 2017

Quick facts

Lead sponsorYangzhou University
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingdouble
Primary purposetreatment
Enrollment240
Start date1 May 2017
Primary completion1 September 2017
Estimated completion1 September 2017
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Yangzhou University

Who can join

Adults 18 to 65, any sex, with Fentanyl-induced Cough. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators aimed to investigate the effects of pretreatment with different doses of dexmedetomidine on the cough caused by fentanyl during anesthetic induction. Patients undergoing elective surgeries under general anesthesia will be randomly allocated to 4 groups (n = 60, each group). Dexmedetomidine 0, 0.03, 0.06, and 0.09 μg/kg/min will be pump-administered in 10 mins to groups I, II, III, and IV, respectively, followed by the induction of general anesthesia with intravenous fentanyl 4 μg/kg. The incidences and severity of cough that occurred within 2 min after the injection of fentanyl will be recorded, and the incidences of cardiovascular adverse events that occurred between the administration of the dexmedetomidine infusion and 2 min after tracheal intubation will be recorded.

Publications & conference data

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

  1. Optimal dose of pretreated-dexmedetomidine in fentanyl-induced cough suppression: a prospective randomized controlled trial.
    Zhou W, Zhang D, Tian S, Yang Y, et al · · 2019 · cited 9× · PMID 31153360 · DOI 10.1186/s12871-019-0765-z

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