Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough

NCT ID: NCT03126422

Last Updated: 2017-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fentanyl-induced Cough

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dexmedetomidine 0 μg/kg/min

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Pretreatment of different doses of dexmedetomidine

Dexmedetomidine 0.03 μg/kg/min

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Pretreatment of different doses of dexmedetomidine

Dexmedetomidine 0.06 μg/kg/min

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Pretreatment of different doses of dexmedetomidine

Dexmedetomidine 0.09 μg/kg/min

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Pretreatment of different doses of dexmedetomidine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

Pretreatment of different doses of dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yangzhou University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhuan Zhang

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhuan Zhang, Professor

Role: CONTACT

+8615062791355

Zhuan Zhang

Role: CONTACT

+8615062791355

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xinnong Liu, Dr.

Role: primary

+8615062791355

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31153360 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20170413

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.