Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough

July 2, 2017 updated by: Zhuan Zhang, Yangzhou University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225012
        • Recruiting
        • the Affiliated Hospital of Yangzhou University, Yangzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine 0 μg/kg/min
Drug: Dexmedetomidine
Pretreatment of different doses of dexmedetomidine
Experimental: Dexmedetomidine 0.03 μg/kg/min
Drug: Dexmedetomidine
Pretreatment of different doses of dexmedetomidine
Experimental: Dexmedetomidine 0.06 μg/kg/min
Drug: Dexmedetomidine
Pretreatment of different doses of dexmedetomidine
Experimental: Dexmedetomidine 0.09 μg/kg/min
Drug: Dexmedetomidine
Pretreatment of different doses of dexmedetomidine

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yangzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 2, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20170413

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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