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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03622502
Other study ID # AJIRB-MED-OBS-18-170
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 16, 2018
Est. completion date March 27, 2019

Study information

Verified date January 2020
Source Ajou University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Administration of dexmedetomidine before end of surgery could reduce airway reflexes and hemodynamic changes during tracheal extubation. Compared with remifentanil alone, administration of dexmedetomidine in combination with remifentanil is effective in relieving cough and hemodynamic changes without inhibition of respiration. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence using the modified up-and-down method.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date March 27, 2019
Est. primary completion date March 22, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- predicted difficult airway

- body mass index > 35 kg/m2,

- recent upper respiratory infection

- asthma

- current smoker

- patients using angiotensin converting enzyme-inhibitors

- uncontrolled hypertension

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
Dexmedetomidine 0.5mcg/kg was infused over 10 min before end of the surgery
Remifentanil
Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 2.0 ng/ml)
Normal saline
Normal saline was infused over 10 min before end of the surgery

Locations

Country Name City State
Korea, Republic of Ajou University Hospital Suwon Gyeongki-do

Sponsors (1)

Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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]
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