UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047384 |
|---|---|
| Receipt number | R000054046 |
| Scientific Title | Comparison of remimazolam and propofol anesthesia for interventional neuroradiology |
| Date of disclosure of the study information | 2022/04/04 |
| Last modified on | 2024/04/04 09:55:21 |
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Basic information
Public title
Comparison of remimazolam and propofol anesthesia for interventional neuroradiology
Acronym
Remimazolam anesthesia for interventional neuroradiology
Scientific Title
Comparison of remimazolam and propofol anesthesia for interventional neuroradiology
Scientific Title:Acronym
Remimazolam anesthesia for interventional neuroradiology
Region
| Asia(except Japan) |
Condition
Condition
IV general anesthesia for interventional neuroradiology
Classification by specialty
| Vascular surgery | Anesthesiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare hemodynamic stability and post-operative recovery between remimazolam and propofol anesthesia in patients who undergo interventional neuroradiology
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Total phenylephrine dose required to restore blood pressure during hypotensive events during the procedure
Key secondary outcomes
- The number of hypotension events
- Intraoperative remifentanil dose
- Time from the end of hemostatic compression to return of spontaneous breathing, time to eye opening, time to extubation, and time to orientation recovery
- Time from the end of hemostatic compression to BIS 75, time from flumazenil injection to extubation, time from flumazenil injection to return of orientation (only in remimazolam group)
- Intraoperative vital signs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the intervention group, general anesthesia is performed using intravenous remimazolam infusion.
Interventions/Control_2
In the intervention group, general anesthesia is performed using intravenous propofol infusion.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- ASA I-III
- Unruptured intracranial aneurysm
- Coiling procedures
Key exclusion criteria
- A ruptured aneurysm
- Multiple aneurysms
- History of neuromuscular/cognitive/psychiatric disease (on medication)
- Preexisting renal or hepatic dysfunction
- Glaucoma
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Jin-Woo |
| Middle name | |
| Last name | Park |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
TEL
82-31-787-7499
jinul8282@gmail.com
Public contact
Name of contact person
| 1st name | Jin-Woo |
| Middle name | |
| Last name | Park |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
TEL
82-31-787-7499
Homepage URL
jinul8282@gmail.com
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
Funding Source
Organization
Seoul National University Bundang Hospital
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seoul National University Bundang Hospital
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
Tel
82-31-787-8801
snubhirb@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
| 2022 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S2352556823001455
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2352556823001455
Number of participants that the trial has enrolled
76
Results
The total phenylephrine dose was lower in the remimazolam group than in the propofol group (p = 0.001). Hypotensive events were observed in 11 patients in the remimazolam group and 23 patients in the propofol group (p = 0.001). Recovery times to spontaneous breathing, eye-opening, extubation, and orientation were shorter in the remimazolam group than in the propofol group (all p < 0.001).
Results date posted
| 2024 | Year | 04 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patient demographic data including age, sex, geight, weight, ASA classification, underlying diseases, and basal MAP were similar between the propofol and remimazolam groups.
Participant flow
Out of the 83 eligible patients, 7 declined to participate in the study, and 76 participants were enrolled in the study.
Patients were randomised between a continuous remimazolam infusion (n = 38) or a target-controlled propofol infusion group (n = 38).
Data collection was completed from all patients without dropping out.
Adverse events
There were hypotensive events in 23 of 38 patients in the propofol group and 11 of 38 patients in the remimazolam group, but these were treated appropriately. There were no other special adverse events.
Outcome measures
The primary outcome was the total phenylephrine dose required to restore blood pressure during hypotensive events during the interventional neuroradiology procedure; a hypotensive event is defined as when the MAP decreases to 80% of the basal MAP, and the number of events was also recorded. Recovery times during emergence from general anaesthesia were investigated by an anaesthesiologist in charge of monitoring patient recovery (time from the end of haemostatic compression to return of spontaneous breathing, time to eye opening, time to extubation, and time to orientation recovery). Before patients were discharged from the post anaesthesia care unit, the incidence of intraoperative memorisation was assessed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054046
