Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough

Phase 1

• Conditions: Fentanyl-induced Cough
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT03126422
• Lead Sponsor: Yangzhou University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-24
• Study Start: 2017-05-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-02
• Last Update Posted: 2017-07-05
• Primary Completion: 2017-09-01
• Study Completion: 2017-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Patients undergoing elective surgeries under general anesthesia.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine 0 μg/kg/min	Dexmedetomidine	-
Dexmedetomidine 0.03 μg/kg/min	Dexmedetomidine	-
Dexmedetomidine 0.06 μg/kg/min	Dexmedetomidine	-
Dexmedetomidine 0.09 μg/kg/min	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China