Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03126422

Enrollment

240

Registered

2017-04-24

Start date

2017-05-01

Completion date

2017-09-01

Last updated

2017-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fentanyl-induced Cough

Brief summary

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.

Interventions

DRUGDexmedetomidine

Pretreatment of different doses of dexmedetomidine

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients undergoing elective surgeries under general anesthesia.

Exclusion criteria

* Patients with contraindications of dexmedetomidine. * Patients younger than 18 years old and older than 65 years old.

Design outcomes

Primary

Measure	Time frame	Description
The incidence of cough	After the infusion of dexmedetomidine up to 10 minutes	Yes or No
The time of cough	After the infusion of dexmedetomidine up to 10 minutes	After the infusion of dexmedetomidine up to 10 minutes
The severity of cough	After the infusion of dexmedetomidine up to 10 minutes	minor, moderate, severe
The occurence of adverse effects of dexmedetomidine	After the infusion of dexmedetomidine up to 10 minutes	bradycardia, hypotension, hypertension

Countries

China

Contacts

Primary ContactZhuan Zhang, Professor

zhangzhuanjy@163.com+8615062791355

Backup ContactZhuan Zhang