Back to resultsEffects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough
Primary Purpose
Fentanyl-induced Cough
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Fentanyl-induced Cough
Eligibility Criteria
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.
Sites / Locations
- the Affiliated Hospital of Yangzhou University, Yangzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Dexmedetomidine 0 μg/kg/min
Dexmedetomidine 0.03 μg/kg/min
Dexmedetomidine 0.06 μg/kg/min
Dexmedetomidine 0.09 μg/kg/min
Arm Description
Outcomes
Primary Outcome Measures
The incidence of cough
Yes or No
The time of cough
After the infusion of dexmedetomidine up to 10 minutes
The severity of cough
minor, moderate, severe
The occurence of adverse effects of dexmedetomidine
bradycardia, hypotension, hypertension
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03126422
Brief Title
Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough
Official Title
Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
September 1, 2017 (Anticipated)
Study Completion Date
September 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fentanyl-induced Cough
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine 0 μg/kg/min
Arm Type
Experimental
Arm Title
Dexmedetomidine 0.03 μg/kg/min
Arm Type
Experimental
Arm Title
Dexmedetomidine 0.06 μg/kg/min
Arm Type
Experimental
Arm Title
Dexmedetomidine 0.09 μg/kg/min
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Pretreatment of different doses of dexmedetomidine
Primary Outcome Measure Information:
Title
The incidence of cough
Description
Yes or No
Time Frame
After the infusion of dexmedetomidine up to 10 minutes
Title
The time of cough
Description
After the infusion of dexmedetomidine up to 10 minutes
Time Frame
After the infusion of dexmedetomidine up to 10 minutes
Title
The severity of cough
Description
minor, moderate, severe
Time Frame
After the infusion of dexmedetomidine up to 10 minutes
Title
The occurence of adverse effects of dexmedetomidine
Description
bradycardia, hypotension, hypertension
Time Frame
After the infusion of dexmedetomidine up to 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuan Zhang, Professor
Phone
+8615062791355
Email
zhangzhuanjy@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuan Zhang
Phone
+8615062791355
Email
zhangzhuanjy@163.com
Facility Information:
Facility Name
the Affiliated Hospital of Yangzhou University, Yangzhou University
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinnong Liu, Dr.
Phone
+8615062791355
Email
zhangzhuanjy@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
31153360
Citation
Zhou W, Zhang D, Tian S, Yang Y, Xing Z, Ma R, Zhou T, Bao T, Sun J, Zhang Z. Optimal dose of pretreated-dexmedetomidine in fentanyl-induced cough suppression: a prospective randomized controlled trial. BMC Anesthesiol. 2019 Jun 1;19(1):89. doi: 10.1186/s12871-019-0765-z.
Results Reference
derived
Learn more about this trial
Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough
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