Effect of Antipsychotic Medication on Remimazolam Sedation During Gastrointestinal Endoscopy

Association Between Antipsychotic Medication Use and Remimazolam Sedation Outcomes During Gastrointestinal Endoscopy: A Prospective Observational Study - REMAPS Study (Remimazolam Sedation in Endoscopy among Patients Receiving Antipsychotics)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060864

Enrollment

110

Registered

2026-03-09

Start date

2026-03-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation during gastrointestinal endoscopy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients scheduled for gastrointestinal endoscopy at our hospital 2.Age >= 18 years at the time of informed consent 3.Patients who provided written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1.History of hypersensitivity to remimazolam. 2.Acute narrow-angle glaucoma. 3.Myasthenia gravis. 4.Hemodynamically unstable patients or those with severe respiratory dysfunction. 5.ASA Physical Status >=3. 6.Alcohol dependence or habitual heavy drinking. 7.Severe cognitive impairment or acute psychiatric conditions that make sedation assessment impossible. 8.Pregnant or breastfeeding women. 9.Patients considered inappropriate for study participation by the investigator.

Design outcomes

Primary

Measure	Time frame
Sedation success rate Defined as completion of the scheduled gastrointestinal endoscopy without the need for additional sedative agents and achieving the target sedation level (MOAA/S =<4) within the maximum remimazolam dose of 8mg.	—

Secondary

Measure	Time frame
1.Total dose of remimazolam required for sedation induction 2.Sedation success rate with the initial dose only 3.Early recovery rate (Proportion of patients capable of walking or achieving an Aldrete score >= 9 within 5 minutes after endoscope withdrawal) 4.Incidence of adverse events (hypotension [SBP < 90 mmHg AND > 20% decrease from baseline], bradycardia, hypoxemia [requiring airway intervention], paradoxical reaction, etc.) 5.Frequency of flumazenil use 6.Endoscopist satisfaction score (0-5 scale)	—

Measure

Time frame

1.Total dose of remimazolam required for sedation induction 2.Sedation success rate with the initial dose only 3.Early recovery rate (Proportion of patients capable of walking or achieving an Aldrete score >= 9 within 5 minutes after endoscope withdrawal) 4.Incidence of adverse events (hypotension [SBP < 90 mmHg AND > 20% decrease from baseline], bradycardia, hypoxemia [requiring airway intervention], paradoxical reaction, etc.) 5.Frequency of flumazenil use 6.Endoscopist satisfaction score (0-5 scale)

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Countries

Japan

Contacts

Public ContactAtsushi Noguchi

Asakayama general hospital Department of Gastroenterology

noguchi@asakayama.or.jp072-229-4882

Outcome results