JPRN-jRCTs031220009
Recruiting
Phase 1
A multicenter exploratory clinical study of sedation depth and safety of intravenous sedation with remimazolam in healthy Japanese male: A single- and continious-dose ascending study
Goto Takashi0 sites72 target enrollmentApril 8, 2022
Conditionsot applicable (healthy adults)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ot applicable (healthy adults)
- Sponsor
- Goto Takashi
- Enrollment
- 72
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy individuals (equivalent to ASA\-PS class 1\)
- •2\. Sex: male
- •3\. Age: between 18 and 45 years old
- •4\. BMI: 18\.5 kg/m2 or more, less than 30 kg/m2
- •5\. Those who voluntarily provided written informed consent upon receiving sufficient explanation and understanding the content of the study
Exclusion Criteria
- •1\. Those who were deemed ineligible for the study based on the results of clinical examination, physiological examinations, electrocardiogram, pulmonary function test, and health examinations for the confirmation of participant characteristics upon screening
- •2\. Those with more than 2\.5 times higher than the upper limit of the facility criteria of the aspartate transaminase and alanine transaminase levels upon screening and total bilirubin level upon screening that was 1\.5 times higher than the facility criteria
- •3\. Those treated for severe or poorly controlled (ASA PS class 3 or greater) respiratory diseases (bronchial asthma, etc.), cardiovascular disease (hypertension, etc.), neurological disorders (convulsions, etc.), digestive diseases, liver diseases, kidney disease, hematopoietic diseases, mental illness, endocrine diseases, etc. or with a history of them who were deemed ineligible for the study for security reasons by the principal investigator or sub\-investigator
- •4\. Those with a history of oversedation or respiratory depression after the administration of benzodiazepines
- •5\. Those with a history of hypersensitivity to benzo diazepines (study drug components) or flumazenil
- •6\. Those with diseases in which benzodiazepines are contraindicated, such as those with acute angle closure glaucoma and myasthenia gravis, or their symptoms
- •7\. Those with a significantly prolonged corrected QT interval (recurrence of QTc \> 450 ms) seen on electrocardiogram
- •8\. Those with Mallampati class 3 or 4
- •9\. Those with high risk of becoming comatosed with respiratory depression due to head injury, bra in tumor, among others
- •10\. Those without the ability to provide informed consent due to complications of dementia, etc.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 4
Comparison of the effects and side effects of sedation with propofol protocol and midazolam and pethidine protocol in endoscopic patients.IRCT2017070834959N1Vice-Chancellor for Research Affairs of Ahvaz Jundishapur University of Medical Sciences.266
Recruiting
Not Applicable
Prospective cohort study of the utility of sedation protocol for the pancreatobiliary endoscopic procedure based on risk classification.JPRN-UMIN000053211Kitasato University School of Medicine2,000
Completed
Not Applicable
A prospective comparative study of the sedation between a combination of propofol and dexmedetomidine hydrochloride and propofol alone in esophageal endoscopic submucosal dissection.JPRN-UMIN000021487Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine60
Not yet recruiting
Not Applicable
Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive ImpairmentMental and behavioural disordersKCT0007184Inha University Hospital100
Completed
Not Applicable
Paediatric accelerator mass spectrometry evaluation research studyISRCTN24569018iverpool Women's NHS Foundation Trust (UK)60