REMIMAZOLAM

Inclusion criteria

• {"criterion_text":"- Patients age ≥ 18 years.\n- Scheduled for a diagnostic upper GI endoscopy with procedural sedation.\n- Ability to provide written informed consent, and to understand the responsibilities of trial participation."}

Exclusion criteria

• {"criterion_text":"- Anticipated use of opioids, such as a therapeutic endoscopy or any other reason.\n- ASA score of 4.\n- Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent."}

Primary endpoints

• {"endpoint_text":"- Time to full alertness, defined as the time interval from the last dosage of the sedative and full alertness. Full alertness is evaluated using the well-known and validated MOAA/S score. This score is developed and validated to measure the level of alertness in subjects who are sedated.(16) Full alertness is defined as the first of 3 consecutive MOAA/S scores of at least 5.(16) The MOAA/S score is described in Appendix I.","definition_or_measurement_approach":"Full alertness is evaluated using the MOAA/S score. Full alertness is defined as the first of 3 consecutive MOAA/S scores of at least 5. The MOAA/S score is described in Appendix I."}

Secondary endpoints

• {"endpoint_text":"- Time interval between patient arrival in the recovery room and full alertness.","definition_or_measurement_approach":"Measured as the time interval between arrival in the recovery room and achievement of full alertness (MOAA/S definition as per primary endpoint)."}
• {"endpoint_text":"- Time to readiness for discharge, defined as the time interval from the last dosage of the sedative to readiness for discharge. Readiness for discharge is evaluated using the well-known and validated Aldrete score. This score is developed to measure when the patient recovery is sufficient for the patient to be discharged home. Readiness for discharge is defined as the first Aldrete score of at least 9.(17) The Aldrete score is described in Appendix II.","definition_or_measurement_approach":"Readiness for discharge evaluated using the Aldrete score; defined as the first Aldrete score of at least 9."}
• {"endpoint_text":"- Patients satisfaction is scored using two different parts of a questionnaire modified from the patient satisfaction with sedation instrument (PSSI). The PSSI is a validated score of procedural sedation satisfaction for outpatient endoscopies.(18) The complete PSSI includes 20 multiple choice type questions which are categorised into 4 sub-scales for describing a patient’s satisfaction. In this study we focused on the PSSI sub-scores for global satisfaction and procedural recall in a modified PSS","definition_or_measurement_approach":"Patient satisfaction measured using two parts of a modified PSSI focusing on global satisfaction and procedural recall (PSSI sub-scores)."}
• {"endpoint_text":"- Endoscopist satisfaction is scored by the endoscopist directly after the procedure (range 0-10, with 0 being the lowest score, and 10 the highest).","definition_or_measurement_approach":"Endoscopist scores satisfaction immediately post-procedure on a 0-10 scale."}
• {"endpoint_text":"- Post-sedation amnesia is scored using a self-developed amnesia test. The test is described in Appendix IV.","definition_or_measurement_approach":"Post-sedation amnesia assessed using a study-specific amnesia test (see Appendix IV)."}
• {"endpoint_text":"- The success rate of sedation, defined as the percentage of procedures which will be finished as intended without requirement of > 5 boluses of midazolam and remimazolam, and without requirement for an alternative sedative.","definition_or_measurement_approach":"Success rate = percentage of procedures completed as intended without >5 boluses of study sedatives and without need for an alternative sedative."}
• {"endpoint_text":"- Incidence of adverse events related to midazolam and remimazolam.","definition_or_measurement_approach":"Incidence of adverse events related to the study drugs captured and reported per standard safety reporting procedures."}

Netherlands

Earliest CTIS Part Ii Submission Date

03-09-2024

Latest Decision Or Authorization Date

05-09-2024

Processing Time Days

2

Number Of Sites

3

Number Of Participants

148

Primary sponsor

Full Name

Sint Antonius Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"Netherlands","full_name":"Sint Antonius Ziekenhuis Stichting","duties_or_roles":"sponsorDuties code 5","organisation_type":"Hospital/Clinic/Other health care facility"}