Remimazolam versus Midazolam for sedation during upper GI endoscopy: a randomized controlled trial

Phase 4

Recruiting

Conditions: N/A

Registration Number: 2024-516432-94-00

Lead Sponsor: Sint Antonius Ziekenhuis Stichting

Brief Summary: To evaluate the duration required for complete patient recovery following the administration of midazolam and remimazolam for procedural sedation during diagnostic upper GI endoscopies.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 148

Inclusion Criteria

Patients age ≥ 18 years.

Scheduled for a diagnostic upper GI endoscopy with procedural sedation.

Ability to provide written informed consent, and to understand the responsibilities of trial participation.

Exclusion Criteria

Anticipated use of opioids, such as a therapeutic endoscopy or any other reason.

ASA score of 4.

Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent.

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.		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.

Secondary Outcome Measures

Name	Time	Method
Time interval between patient arrival in the recovery room and full alertness.		Time interval between patient arrival in the recovery room and full alertness.
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.		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.
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		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
Endoscopist satisfaction is scored by the endoscopist directly after the procedure (range 0-10, with 0 being the lowest score, and 10 the highest).		Endoscopist satisfaction is scored by the endoscopist directly after the procedure (range 0-10, with 0 being the lowest score, and 10 the highest).
Post-sedation amnesia is scored using a self-developed amnesia test. The test is described in Appendix IV.		Post-sedation amnesia is scored using a self-developed amnesia test. The test is described in Appendix IV.
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.		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.
Incidence of adverse events related to midazolam and remimazolam.		Incidence of adverse events related to midazolam and remimazolam.

Trial Locations

Locations (3): Gelre Hospitals
🇳🇱
Apeldoorn, Netherlands
Sint Antonius Ziekenhuis Stichting
🇳🇱
Nieuwegein, Netherlands
Rijnstate Ziekenhuis Stichting
🇳🇱
Arnhem, Netherlands
Gelre Hospitals
🇳🇱Apeldoorn, Netherlands
Nicoline van Heel
Site contact
0555818030
n.van.heel@gelre.nl