UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040950 |
|---|---|
| Receipt number | R000046759 |
| Scientific Title | Comparison of Safety and Efficacy of Nurse- Administered Discharge Criteria using Aldrete Scoring System (ASS) versus Modified Post Anaesthetic Discharge Scoring System (MPADSS) in Sedation of Gastrointestinal Endoscopy |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2022/12/31 09:31:05 |
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Basic information
Public title
Comparison of Safety and Efficacy of Nurse- Administered Discharge Criteria using Aldrete Scoring System (ASS) versus Modified Post Anaesthetic Discharge Scoring System (MPADSS) in Sedation of Gastrointestinal Endoscopy
Acronym
Aldrete scoring study
Scientific Title
Comparison of Safety and Efficacy of Nurse- Administered Discharge Criteria using Aldrete Scoring System (ASS) versus Modified Post Anaesthetic Discharge Scoring System (MPADSS) in Sedation of Gastrointestinal Endoscopy
Scientific Title:Acronym
Aldrete scoring study
Region
| Japan |
Condition
Condition
Patients undergoing gastrointestinal endoscopy under sedation with Midazolam
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the safety and efficacy of Nurse-Administered Discharge Criteria using Aldrete scoring system with previous MPADSS in patients after sedation of gastrointestinal endoscopy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recovery time after sedation of gastrointestinal endoscopy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
questionnaire
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who consent to participate in this study
2) adult over 20 years old
Key exclusion criteria
1) patients planned endoscopic therapy
2) patients who received endoscopic treatment
3) patients who themselves do not understand the use of sedation
4) patients using anesthetic drug other than midazolam
5) patients with severe complications (heart failure, renal failure, liver failure, respiratory failure)
6) pregnancy or lactation patients
7) patients with history of allergy to midazolam
8) patients who did not obtain consent to participate in this study
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
Ureshino Medical Center
Division name
Gastroenterology
Zip code
843-0393
Address
Shimojyukukou 4279-3, Ureshino city, Japan
TEL
0954-43-1120
daisukehawks@gmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
Ureshino Medical Center
Division name
Gastroenterology
Zip code
843-0393
Address
Shimojyukukou 4279-3, Ureshino city, Japan
TEL
0954-43-1120
Homepage URL
daisukehawks@gmail.com
Sponsor or person
Institute
Ureshino Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Ureshino Medical Center
Address
Shimojyukukou 4279-3, Ureshino city, Japan
Tel
0954-43-1120
daisukehawks@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-022-02549-7
Publication of results
Published
Result
URL related to results and publications
https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-022-02549-7
Number of participants that the trial has enrolled
376
Results
The proportion of patients who had a recovery time within 60 min after endoscopy was significantly higher in group A than that in group M (42.5% versus 25.0%; P < 0.01). The proportion of patients who required > 120 min of recovery time after endoscopy was significantly lower in group A than that in group M (0.0% versus 5.0%; P = 0.03). However, significantly more patients had drowsiness at discharge in group A compared with group M (19.1% versus 5.0%; P < 0.01).
Results date posted
| 2022 | Year | 12 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The present study enrolled outpatients who underwent sedative endoscopy at the National Hospital Organization Ureshino Medical Center from two prospective studies that analyzed the usefulness of MPADSS and the modified Aldrete score, respectively, as discharge standards. Outpatients > 20 years of age who underwent esophagogastroduodenoscopy, colonoscopy, or endoscopic ultrasonography under sedation were candidates for the present study. Intravenous sedation was not generally used in patients allergic to midazolam or in pregnant or breastfeeding women, thus excluding these patients. Outpatients who underwent therapeutic endoscopy were also excluded from the present study.
Participant flow
We prospectively enrolled 376 outpatients who underwent gastrointestinal endoscopy under midazolam sedation; 181 outpatients were assessed regarding discharge after sedative endoscopy using the MPADSS (group M), and 195 patients were assessed by the modified Aldrete score (group A).
Propensity-score matching created 120 matched pairs.
Adverse events
Drowsiness was seen more frequently in patients in group A compared with group M as an adverse event before discharge (5.0% versus 19.1%, respectively; P < 0.01), whereas no other adverse event rates differed between the groups. In group M, one patient required hospitalization because of inadequate arousal after sedative endoscopy.
While drowsiness was the most frequent adverse event within 24 h in both groups, the rates of adverse events within 24 h of discharge were not significantly different between the two groups. Most of the adverse symptoms were mild and resolved within 24 h. However, three patients in group M and two patients in group A returned to the hospital within 24 h of discharge for further observation. One of these patients was admitted to the hospital at the patient's request.
Outcome measures
The primary endpoint of the present study was the difference in the discharge time after sedative endoscopy between the two groups. The secondary endpoint was the difference in the adverse events rate before discharge, need for hospitalization, and adverse events within 24 h after discharge between the two groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 29 | Day |
Last modified on
| 2022 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046759
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