NCT03622502

Brief Summary

Dexmedetomidine or remifentanil are effective in attenuating cough during peri-extubation period after general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

August 16, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

August 6, 2018

Last Update Submit

January 6, 2020

Conditions

Keywords

dexmedetomidineremifentanilextubation

Outcome Measures

Primary Outcomes (1)

  • Number of cough

    Number of cough or a strong and sudden contraction of the abdomen during periextubation periextubation periods

    from end of surgery to 5 min after tracheal extubation]

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine was infused before end of surgery and remifentanil was maintained at predetermined effect-site concentration during the emergence period

Drug: DexmedetomidineDrug: Remifentanil

Remifentanil

ACTIVE COMPARATOR

Normal saline was infused before end of surgery and remifentanil was maintained at predetermined effect-site concentration during the emergence period

Drug: RemifentanilDrug: Normal saline

Interventions

Dexmedetomidine 0.5mcg/kg was infused over 10 min before end of the surgery

Also known as: Prededex
Dexmedetomidine

Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 2.0 ng/ml)

Also known as: Ultiva
DexmedetomidineRemifentanil

Normal saline was infused over 10 min before end of the surgery

Also known as: 0.9% NaCl
Remifentanil

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I or II undergoing endoscopic sinus surgery or septoplasty under general anesthesia

You may not qualify if:

  • predicted difficult airway
  • body mass index \> 35 kg/m2,
  • recent upper respiratory infection
  • asthma
  • current smoker
  • patients using angiotensin converting enzyme-inhibitors
  • uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, Gyeongki-do, 443-721, South Korea

Location

Related Publications (1)

  • Kim HY, Kwak HJ, Lee D, Lee JH, Min SK, Kim JY. Comparison of remifentanil concentrations with and without dexmedetomidine for the prevention of emergence cough after nasal surgery: a randomized double-blinded trial. BMC Anesthesiol. 2021 May 4;21(1):136. doi: 10.1186/s12871-021-01358-x.

MeSH Terms

Conditions

Cough

Interventions

DexmedetomidineRemifentanilSaline Solution

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jong Yeop Kim

    Ajou University Hospital, Suwon, Gyeongki-do, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 9, 2018

Study Start

August 16, 2018

Primary Completion

March 22, 2019

Study Completion

March 27, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations