2.5.1. Overview of treatment (protocol treatment).
respiratory depression, drowsiness, somnolence
RESPIRATORY DEPRESSION
In a randomized comparative study of 2 groups, the NHF device use group and the nasal cannula use group, for adult patients who visited the Department of Optical Medicine, Nagasaki University Hospital and underwent ERCP examination and treatment under sedation during hospitalization. Patients who meet the enrollment requirements will be randomly assigned to either the device use group or the nasal cannula use group after obtaining consent (ratio 1:1). Patients are enrolled in patients undergoing ERCP under sedation with Dexmedetomidine. The patient is placed in the examination position on the examination table in the endoscopy room. Patients assigned to the NHF device group inserted a cannula of the NHF device AIRVO3 from both nasal cavities and inhale humidified air and 100% oxygen (% FiOSedation is performed using Dexmedetomidine and Midazolam in combination, and the recommended dose in the guideline is administered according to the administration protocol of the usual medical treatment by ERCP at Nagasaki University Optical Clinic. After changing the position, attach various monitors and measure the basic value of each monitor. Dexmedetomidine is administered at 6 μg/kg/hour for 5 minutes as the initial loading administration, and midazolam is administered at 0.05 mg/kg at the same time, and pethidine hydrochloride 1 A (35 mg) is further administered as an analgesic. After completing the administration of Dexmedetomidine at 6 μg/kg/hour for a total of 10 minutes as the initial load administration, change the Dexmedetomidine to 0.7 μg/kg/hour and continue, carefully shifting to sedation maintenance and optimal sedation (30–50 for SEDLINE, 5–6 for RAMSAY SCORE). When the patient falls asleep, insert the scope and start the procedure. At this point, if the patient body movement is observed, add 0.05 mg/kg of midazolam.When additional intravenous pethidine hydrochloride is administered, the administration unit is 17.5 mg, and when used in combination with Dexmedetomidine, the Ramsay Score is 5 (slow response to light tapping to the drowsiness between the eyebrows or strong auditory stimulus) to 6 (no response to stimulus). In order to maintain a sedation level of about 30 to 50, pethidine hydrochloride is administered 17.5 mg intermittently, and a total of 105 to 140 mg should be administered. As a guide, administer as needed to maintain the same degree of sedation. The additional dose of pethidine hydrochloride should be 17.5 mg per dose, and the respiratory depression caused by the administration of pethidine hydrochloride in a short period of time should be carefully determined.(Reference: Ramsay Score score 5 (slowly responds to somnolence between the eyebrows or strong auditory stimuli) and 6 (no response to stimulus))Using SEDLINE as a sedation monitor, continuous measurement of sedation is performed, an electroencephalogram electrode is attached to the forehead, recorded in the device, and externally output to a USB medium after the test is completed.A normal sphygmomanometer, electrocardiogram, and percutaneous oxygen saturation measuring probe used during examination and treatment are attached to the finger, and a percutaneous COPercutaneous CORespiratory rate detection uses the respiratory detection function of RADICAL7 to continuously record the respiratory rate. In addition, the respiratory rate is evaluated from the impedance change between the electrodes of the 3-pole standard lead of the electrocardiogram in case the measured value becomes inaccurate due to noise mixed under the influence of NHF.