Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough

Fentanyl-induced Cough Clinical Trial

Official title:

Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03126422
• Other study ID #: 20170413
• Status: Recruiting
• Phase: Phase 1
• First received: April 14, 2017
• Last updated: July 2, 2017
• Start date: May 1, 2017
• Est. completion date: September 1, 2017

Study information

• Verified date: July 2017
• Source: Yangzhou University
• Contact: Zhuan Zhang, Professor
• Phone: +8615062791355
• Email: zhangzhuanjy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cough
• Fentanyl-induced Cough

Intervention

Drug:
• Dexmedetomidine
Pretreatment of different doses of dexmedetomidine

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

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