UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055082 |
|---|---|
| Receipt number | R000062923 |
| Scientific Title | The incidence of connected consciousness in patients undergoing general anaesthesia with remimazolam |
| Date of disclosure of the study information | 2024/07/26 |
| Last modified on | 2024/07/26 11:34:34 |
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Basic information
Public title
The incidence of connected consciousness in patients undergoing general anaesthesia with remimazolam
Acronym
The incidence of connected consciousness in patients undergoing general anaesthesia with remimazolam
Scientific Title
The incidence of connected consciousness in patients undergoing general anaesthesia with remimazolam
Scientific Title:Acronym
The incidence of connected consciousness in patients undergoing general anaesthesia with remimazolam
Region
| Japan |
Condition
Condition
diseases requiring surgery under general anaesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
General anaesthesia is a state of unconsciousness and unresponsiveness, but intraoperative consciousness, in which the experience during general anaesthesia can be clearly recalled, occurs rarely. On the other hand, Connected Consciousness, which cannot be recalled post-operatively but allows the patient to follow commands through subconscious awareness, is said to occur at a higher rate (5-10%). The aim of the present study is to examine the incidence of connected consciousness in patients undergoing general anaesthesia with remimazolam.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of patients with positive 'connected awareness' responding to commands after supraglottic instrument insertion
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After insertion of the supraglottic instrument, the patient is asked to listen to a series of commands, sentences and words and their response to the commands is assessed.
At the end of the operation and on arrival at the ward, the following should be performed and assessed
1. the word retrieval task in Supplementary Figure 3.
2. modified Brice questionnaire
3. assessment of the presence of delirium (Nursing Delirium Screening Scale)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(i) Patients aged 18 years or older at the time of obtaining consent.
(ii) Patients undergoing general anaesthesia
(iii) Patients with the American Society of Anesthesiologists physical status 1 or 2
(iv) Patients who have received a full explanation of their participation in this study, and who have given written consent of their own free will based on full understanding.
Key exclusion criteria
(i) Patients who cannot give consent.
(ii) Patients who cannot speak Japanese
(iii) Patients undergoing emergency surgery
(iv) Patients undergoing rapid induction
(v) Other patients deemed unsuitable as subjects by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Yaguchi |
Organization
Hitachi General Hospital
Division name
anaesthesiology
Zip code
317-0077
Address
2-1-1 Jonancho, Hitachi-shi, Ibaraki-ken
TEL
0294-23-1111
tshiraishi.1217@gmail.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Shiraishi |
Organization
Hitachi General Hospital
Division name
anaesthesiology
Zip code
317-0077
Address
2-1-1 Jonancho, Hitachi-shi, Ibaraki-ken
TEL
0294-23-1111
Homepage URL
tshiraishi.1217@gmail.com
Sponsor or person
Institute
Hitachi General Hospital
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
Hitachi General Hospital
Address
2-1-1 Jonancho, Hitachi-shi, Ibaraki-ken
Tel
0294-23-1111
tshiraishi.1217@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
| 2024 | Year | 07 | Month | 26 | 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
| 2024 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 26 | Day |
Last modified on
| 2024 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062923
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| Registered date | File name |
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