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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02973724
Other study ID # AJIRB-MED-CT4-16-349
Secondary ID
Status Completed
Phase N/A
First received November 21, 2016
Last updated June 8, 2017
Start date November 2016
Est. completion date June 2017

Study information

Verified date June 2017
Source Ajou University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigator designed this study to investigate remifentanil effect-site concentration in 95% of patients (EC95) for preventing cough after laryngomicrosurgery from propofol anesthesia.


Description:

At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to predetermined (initial concentration 1.0 ng/ml for the first patient). Extubation was performed when the patients opened their eyes and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria:

- ASA I-II patients undergoing general anesthesia for laryngomicrosurgery

Exclusion Criteria:

- Anticipated difficult airway

- COPD, Asthma

- Recent URI (< 2 weeks)

- Severe cardiac, hepatic renal disease

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Remifentanil
The concentration of remifentanil was determined by biased-coin up and down design, starting from 1.0 ng/ml (0.4 ng/ml as a step size)
Propofol anesthesia
Anesthesia was induced with propofol target-controlled infusion at an effect-site concentration of 5.0 µg/ml.

Locations

Country Name City State
Korea, Republic of Ajou University Hospital Suwon Gyeonggi-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 periods from end of surgery to 5 min after tracheal extubation
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