Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614036
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Remimazolam Versus Midazolam for Sedation During Upper GI Endoscopy a Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Remimazolam Versus Midazolam for Sedation During Upper GI Endoscopy a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REST
Brief Summary:
Rationale Midazolam is known for its safety effectiveness for procedural sedation during gastrointestinal GI endoscopy and is used as standard sedative by endoscopists worldwide Remimazolam is a novel recently approved sedative with the potential to facilitate a faster neuropsychiatric recovery Therefore it may potentially enable earlier discharge and improvement of post-procedural memory compared to midazolam Furthermore remimazolam may enhance patient satisfaction
Objective The investigators aim to compare the use of remimazolam and midazolam for sedation during diagnostic upper GI endoscopies in a randomized clinical trial
Main trial endpoints Time to full alertness time interval from the last dosage midazolam or remimazolam to the first of 3 consecutive MOAAS scores of 5
Secondary trial endpoints Interval between arrival in the recovery room and full alertness patient satisfaction based on questionnaire after discharge and after 1 day duration of amnesia based on memory test after 1 day time interval between last dosage of sedative and readiness for discharge first Aldrete score of at least 9 total dosage and number of boluses for adequate sedation time interval between first dosage of sedative and start of the procedure endoscopist satisfaction scored 0-10 after the procedure
Trial design Randomized multicenter double blind clinical trial which will take 2 days for study participants
Trial population Adult patients scheduled for diagnostic upper GI endoscopy with sedation The anticipated use of fentanyl or other opioids during endoscopy is an exclusion criterium n148 patients
Interventions Participants will be randomly assigned to receive either remimazolam or midazolam as a sedative and will be followed up until one day after the procedure One group will receive midazolam as a sedative and another group will receive remimazolam as a sedative Both agents will be administered in accordance with current guidelines Vital signs MOAAS scores and Aldrete scores will be monitored Additionally a memory test and a questionnaire will be administered to the participants
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks This study aims to evaluate two procedures employed in regular daily care Both sedatives used in this study are considered safe and effective for procedural sedation Therefore the investigators anticipate minimal risk for the participants involved in the study Participants will not be subjected to any additional interventions or hospital visits apart from randomization data collection and two short questionnaires to evaluate amnesia and patient satisfaction There will be no direct benefits for the participants as a result of their participation in this study
Objective The investigators aim to compare the use of remimazolam and midazolam for sedation during diagnostic upper GI endoscopies in a randomized clinical trial
Main trial endpoints Time to full alertness time interval from the last dosage midazolam or remimazolam to the first of 3 consecutive MOAAS scores of 5
Secondary trial endpoints Interval between arrival in the recovery room and full alertness patient satisfaction based on questionnaire after discharge and after 1 day duration of amnesia based on memory test after 1 day time interval between last dosage of sedative and readiness for discharge first Aldrete score of at least 9 total dosage and number of boluses for adequate sedation time interval between first dosage of sedative and start of the procedure endoscopist satisfaction scored 0-10 after the procedure
Trial design Randomized multicenter double blind clinical trial which will take 2 days for study participants
Trial population Adult patients scheduled for diagnostic upper GI endoscopy with sedation The anticipated use of fentanyl or other opioids during endoscopy is an exclusion criterium n148 patients
Interventions Participants will be randomly assigned to receive either remimazolam or midazolam as a sedative and will be followed up until one day after the procedure One group will receive midazolam as a sedative and another group will receive remimazolam as a sedative Both agents will be administered in accordance with current guidelines Vital signs MOAAS scores and Aldrete scores will be monitored Additionally a memory test and a questionnaire will be administered to the participants
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks This study aims to evaluate two procedures employed in regular daily care Both sedatives used in this study are considered safe and effective for procedural sedation Therefore the investigators anticipate minimal risk for the participants involved in the study Participants will not be subjected to any additional interventions or hospital visits apart from randomization data collection and two short questionnaires to evaluate amnesia and patient satisfaction There will be no direct benefits for the participants as a result of their participation in this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None