UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060864 |
|---|---|
| Receipt number | R000069641 |
| Scientific Title | Association Between Antipsychotic Medication Use and Remimazolam Sedation Outcomes During Gastrointestinal Endoscopy: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/03/09 |
| Last modified on | 2026/03/07 00:35:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Antipsychotic Medication on Remimazolam Sedation During Gastrointestinal Endoscopy
Acronym
REMAPS Study (Remimazolam Sedation in Endoscopy among Patients Receiving Antipsychotics)
Scientific Title
Association Between Antipsychotic Medication Use and Remimazolam Sedation Outcomes During Gastrointestinal Endoscopy: A Prospective Observational Study
Scientific Title:Acronym
REMAPS Study (Remimazolam Sedation in Endoscopy among Patients Receiving Antipsychotics)
Region
| Japan |
Condition
Condition
Sedation during gastrointestinal endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness and safety of remimazolam sedation in patients receiving antipsychotic medications undergoing gastrointestinal endoscopy.
We will compare sedation success rate, total dose of remimazolam, and incidence of adverse events between patients taking antipsychotic medications and those not taking them.
The study aims to clarify whether antipsychotic medication independently affects the sedative efficacy of remimazolam.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Noguchi |
Organization
Asakayama general hospital
Division name
Department of Gastroenterology
Zip code
590-0018
Address
3-3-16 Imaikecho, Sakai-ku, Sakai City, Osaka
TEL
072-229-4882
noguchi@asakayama.or.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Noguchi |
Organization
Asakayama general hospital
Division name
Department of Gastroenterology
Zip code
590-0018
Address
3-3-16 Imaikecho, Sakai-ku, Sakai City, Osaka
TEL
072-229-4882
Homepage URL
noguchi@asakayama.or.jp
Sponsor or person
Institute
Asakayama general hospital
Institute
Department
Personal name
Atsushi Noguchi
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asakayama General Hospital IRB
Address
3-3-16 Imaikecho, Sakai-ku, Sakai City, Osaka
Tel
072-229-4882
asaka@asakayama.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
公益財団法人浅香山病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Note: This is an observational study, and the following describes procedures performed and observed within routine clinical practice.
Sedation using intravenous Remimazolam during gastrointestinal endoscopy.
Sedation will be performed according to standard clinical practice in our hospital.
Initial dose:3 mg intravenous bolus.For elderly or low body weight patients, the initial dose may be reduced to 1.5-2 mg at the discretion of the physician.
Additional dose:1 mg may be administered at intervals of >=1 minute until adequate sedation is achieved.
Maximum dose before endoscope insertion:8 mg.
Sedation depth will be evaluated using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score.
Target sedation level: MOAA/S score <=4.
If adequate sedation cannot be achieved with the maximum dose of remimazolam, rescue sedatives (e.g., propofol or flunitrazepam) may be administered at the physician's discretion.
Participants will be classified into two groups based on medication history.
Antipsychotic group
Patients receiving typical or atypical antipsychotic medications continuously for at least one month prior to endoscopy.
Control group
Patients not receiving antipsychotic medications.
Concomitant use of benzodiazepines, non-benzodiazepine hypnotics, and orexin receptor antagonists is permitted in both groups.
Management information
Registered date
| 2026 | Year | 03 | Month | 07 | Day |
Last modified on
| 2026 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069641
