Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJuly 5, 2017
July 1, 2017
4 months
April 14, 2017
July 2, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
The incidence of cough
Yes or No
After the infusion of dexmedetomidine up to 10 minutes
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
minor, moderate, severe
After the infusion of dexmedetomidine up to 10 minutes
The occurence of adverse effects of dexmedetomidine
bradycardia, hypotension, hypertension
After the infusion of dexmedetomidine up to 10 minutes
Study Arms (4)
Dexmedetomidine 0 μg/kg/min
EXPERIMENTALDexmedetomidine 0.03 μg/kg/min
EXPERIMENTALDexmedetomidine 0.06 μg/kg/min
EXPERIMENTALDexmedetomidine 0.09 μg/kg/min
EXPERIMENTALInterventions
Pretreatment of different doses of dexmedetomidine
Eligibility Criteria
You may qualify if:
- Patients undergoing elective surgeries under general anesthesia.
You may not qualify if:
- Patients with contraindications of dexmedetomidine.
- Patients younger than 18 years old and older than 65 years old.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu, 225012, China
Related Publications (1)
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.
PMID: 31153360DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
April 14, 2017
First Posted
April 24, 2017
Study Start
May 1, 2017
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
July 5, 2017
Record last verified: 2017-07