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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs072210047

Registered date:28/07/2021

Examination of stabilization of sedation by Nasal High Flow in patients with endoscopic retrograde cholangiopancreatography during sedation using Dexmedetomidine

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBiliary disease
Date of first enrollment17/05/2022
Target sample size118
Countries of recruitment
Study typeInterventional
Intervention(s)NHF intervention

Outcome(s)

Primary Outcometotal dose of pethidine, an analgesic used in combination
Secondary Outcome1) Occurrence rate of marked hypercapnia showing a maximum percutaneous carbon dioxide concentration of 60 mmHg or more (corresponding to PaCO2> 55 mmHg) during intravenous anesthesia. 2) Area under the curve (AUC) of percutaneous carbon dioxide concentration per unit time during intravenous anesthesia 3) Duration of moderate hypercapnia showing a maximum percutaneous carbon dioxide concentration of 50 mmHg or more (equivalent to PaCO2> 45 mmHg) during intravenous anesthesia 4) Incidence of hypoxemia with percutaneous oxygen saturation of 90% or less during intravenous anesthesia 5) Respiratory rate using Radical 7 6) Respiratory rate from changes in impedance of ECG electrodes 7) Total dose of sedative (Dexmedetomidine and Midazolam), dose per anesthesia time 8) Sedation level using SEDLINE 9) Ramsay scale, which is an objective evaluation

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 85age old
GenderBoth
Include criteria1)Age: Adult patients whose age is between 20 a nd 85 years old at the time of obtaining consent 2)Gender: Any question 3)Hospitalization / outpatient: hospitalization onl y 4)Patients who have received sufficient explanati on for participation in this study, and who have re ceived sufficient written consent from the patient himself / herself with sufficient understanding.
Exclude criteria1)Cases of postoperative reconstructed intestinal tract 2) Continuous administration of oxygen by nasal cannula (home oxygen therapy) 3)Patients who cannot breathe nose 4)Patients who cannot reduce or discontinue anti thrombotic drugs on the day before the endoscope 5)Patients with a history of pneumothorax 6) Patients who are positive for the new coronavirus (SARS-CoV-2) PCR test 7)Patients with a history of bronchial asthma attack or severe asthma 8) Other patients who are determined to be inappropriate as research subjects by the principal investigator

Related Information

Contact

Public contact
Name Takao Ayuse
Address 1-7-1 Sakamoto Nagasaki Japan Nagasaki Japan 852-8501
Telephone +81-95-819-7713
E-mail ayuse@nagasaki-u.ac.jp
Affiliation Nagasaki University Hospital
Scientific contact
Name Takao Ayuse
Address 1-7-1 Sakamoto nagasaki Japan Nagasaki Japan 852-8501
Telephone +81-95-819-7713
E-mail ayuse@nagasaki-u.ac.jp
Affiliation Nagasaki University Hspital