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

JRCT ID: jRCTs072210047

Registered date:28/07/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Biliary disease
• Date of first enrollment: 28/07/2021
• Target sample size: 118
• Study type: Interventional
• Intervention(s): NHF intervention

Outcome(s)

• Primary Outcome: total dose of pethidine, an analgesic used in combination

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Ayuse Takao
• Source(s) of Monetary Support: Fisher &amp; Paykel Healthcare Limited