Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Remimazolam Besylate 20 mg Lyophilized Powder for Injection: An initial dose of 2 mL study medication will be administered manually by IV injection over one minute. Supplemental doses o
Sponsors
Enaltec Labs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients, aged 18 to 60 years (both inclusive), scheduled to undergo a diagnostic or therapeutic procedures which lasts 30 minutes or less (i.e., colonoscopy and bronchoscopy etc.). 2. Patients with American Society of Anesthesiologists physical status classification system score of I, II or III. 3. Patients with body mass index range of greater than or equal to 18 to smaller than or equal to 40 kg per m2. 4. Women of childbearing potential must have a negative result of pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy during the study period. 5. Patient with ability to understand and provide written, signed and dated informed consent form, which must have been obtained prior to screening. 6. Patient willing and able to comply with all the study requirements and return for a follow-up visit on Day 4 after the procedure.
Exclusion criteria
Exclusion criteria: 1. Patients with a known sensitivity to benzodiazepines, Flumazenil, opioids, Naloxone, or a medical condition such that these agents are contraindicated. 2. Patients expected duration of procedure greater than 30 minutes. 3. Patients with a suspected or diagnosed pathology of the lower GI tract that would have added to the risk of colonoscopy, such as strictures, active inflammatory bowel disease. 4. Patients with chronic use of benzodiazepines for any indication (e.g., insomnia, anxiety and spasticity). 5. Patients with chronic use of opioids for any indication. 6. Female patients who are pregnant or breast feeding. 7. Patients with evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction, or other clinically significant findings at screening that, in the investigator s opinion, should have excluded them from the study. 8. Patients in whom management of airway is judged to be difficult due to, e.g., thyro-mental distance smaller than or equal to 4 cm ( short neck ), or modified Mallampati score of IV. 9. Patients with clinically significant abnormalities in 12 lead ECG recorded at screening. 10. Patients with a positive serum ethanol at baseline. 11. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 2.5X the ULN and/or Total bilirubin more than 1.5X the ULN) at screening. 12. Patients with clinically significant impaired renal function (BUN and Serum creatinine more than the upper limit of normal) at screening. 13. Patients with known case of anemia or thrombocytopenia, (hemoglobin less than 9 g per dL, platelet count less than 80 109 per L) at screening. 14. Patients with uncontrolled hypertension with sitting systolic blood pressure greater than or equal to 160 mmHg and or diastolic blood pressure greater than or equal to 100 mmHg at screening. 15. Patients diagnosed with heart disease (heart failure, angina pectoris, myocardial infarction and heart rhythm abnormalities). 16. Patients with a history of substance or alcohol abuse or dependence within the past 2 years. 17. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent form. 18. Patients currently taking any of the prohibited medications(s) and inability or unwillingness to discontinue them for the entire study period. 19. Patients with suspected inability or unwillingness to comply with the study procedures. 20. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful completion of the procedure, defined as follows: Completion of the procedure, AND No requirement for a rescue sedative medication, AND No requirement for more than five doses of Remimazolam within any 15-minute window, OR No requirement for more than three doses of Midazolam within any 12-minute window. Timepoint: Visit 4 - End of the study or Day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to start of procedure after administration of the first dose of study medication.Timepoint: Visit 3 - Randomization or Day 1;Time to peak sedation after administration of the first dose of study medication, assessed using the Modified Observer s Assessment of Alertness/Sedation (MOAA/s) score. Times to ready for discharge after the end of procedure and after the last injection of study drug (defined as ability to walk unassisted). Times to fully alert (time to first of 3 consecutive MOAA/S scores of 5 after the end of procedure and after last injection of study drug). Timepoint: Visit 3 - Randomization or Day 1;Recall of the procedure by the Brice questionnaire administered when full alertness is regained and on day 4.Timepoint: Visit 4 - End of the study or Day 4;Ready to discharge 30, 60, and 90 minutes after injection of the initial dose. Assessment of re-sedation using a visual analogue scale for drowsiness. Requirement for Flumazenil during the procedure.Timepoint: Visit 3 - Randomization or Day 1;Pain on injection at application of the study medication.Timepoint: Visit 3 - Randomization or Day 1;Adverse events and serious adverse events reported during the study. Timepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactMr Rajendrakumar Gurav
Clinwave Research Pvt. Ltd.
Outcome results
None listed