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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs072210047

Enrollment

118

Registered

2021-07-28

Start date

2022-05-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary disease

Interventions

NHF intervention

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)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.

Exclusion criteria

Exclusion criteria: 1)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

Design outcomes

Primary

Measure	Time frame
total dose of pethidine, an analgesic used in combination	—

Secondary

Measure	Time frame
1) 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	—

Measure

Time frame

1) 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

—

Contacts

Public ContactTakao Ayuse

Nagasaki University Hospital

ayuse@nagasaki-u.ac.jp+81-95-819-7713

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026