UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062363 |
|---|---|
| Receipt number | R000071373 |
| Scientific Title | A Study on the Effects of Induction with Propofol or Remimazolam on Hemodynamic Parameters |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/29 16:55:54 |
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Basic information
Public title
A study investigating how blood pressure and heart rate change when starting general anesthesia with different medications (propofol or remimazolam).
Acronym
A Study on the Effects of Induction with Propofol or Remimazolam on Hemodynamic Parameters
Scientific Title
A Study on the Effects of Induction with Propofol or Remimazolam on Hemodynamic Parameters
Scientific Title:Acronym
A Study on the Effects of Induction with Propofol or Remimazolam on Hemodynamic Parameters
Region
| Japan |
Condition
Condition
Young and healthy adult patients aged 18 to 39 years with an ASA physical status of 1 or 2 undergoing oral and maxillofacial surgery.
Classification by specialty
| Oral surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Propofol is currently the most widely used general anesthetic and is a highly useful agent; however, it has certain limitations, including the risk of allergic reactions in patients with soybean or egg allergies and the occurrence of injection pain. Furthermore, propofol is characterized by a relatively strong cardiovascular suppressive effect. On the other hand, although basic research has reported that the effects of remimazolam, a novel general anesthetic for induction and maintenance, on hemodynamics are milder than those of propofol, there have been no clinical reports comparing the two when used in combination with opioids in actual clinical practice. Clarifying the effects of remimazolam on hemodynamics in a clinical setting through this study is expected to expand the options available for total intravenous anesthesia.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage changes from baseline in hemodynamic parameters - including systolic and diastolic blood pressure (SBP and DBP), heart rate (HR), cardiac output (CO), stroke volume (SV), stroke volume index (SVI), and cardiac index (CI) - over time from the induction of general anesthesia to 5 minutes after tracheal intubation.
Key secondary outcomes
Percentage change from baseline in the Bispectral Index (BIS) over time from the induction of general anesthesia to 5 minutes after tracheal intubation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After obtaining control values (pre-anesthesia values), remifentanil is administered at 0.3 ug/kg/min for 1 minute. Propofol is administered via TCI at 5 ug/ml (maintained at 3 times the effect-site concentration for loss of consciousness). Following loss of consciousness, rocuronium (0.6 mg/kg) is administered, and endotracheal intubation is performed at least 5 minutes after administration when the train-of-four (TOF) count reaches 0.
Interventions/Control_2
After obtaining control values (pre-anesthesia values), remifentanil is administered at 0.3 ug/kg/min for 1 minute. Propofol is administered via TCI at 4 ug/ml (maintained at 3 times the effect-site concentration for loss of consciousness). Following loss of consciousness, rocuronium (0.6 mg/kg) is administered, and endotracheal intubation is performed at least 5 minutes after administration when the train-of-four (TOF) count reaches 0.
Interventions/Control_3
After obtaining control values (pre-anesthesia values), remifentanil is administered at 0.3 ug/kg/min for 1 minute. Remimazolam is administered at 0.3 mg/kg at a rate of 12 mg/kg/h, and then maintained at 1 mg/kg/h. Following loss of consciousness, rocuronium (0.6 mg/kg) is administered, and endotracheal intubation is performed at least 5 minutes after administration when the train-of-four (TOF) count reaches 0.
Interventions/Control_4
After obtaining control values (pre-anesthesia values), remifentanil is administered at 0.3 ug/kg/min for 1 minute. Remimazolam is administered at 0.2 mg/kg at a rate of 12 mg/kg/h, and then maintained at 1 mg/kg/h. Following loss of consciousness, rocuronium (0.6 mg/kg) is administered, and endotracheal intubation is performed at least 5 minutes after administration when the train-of-four (TOF) count reaches 0.
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age: Healthy adults aged 18 to 39 years (ASA-PS physical status 1 or 2)
Patient Background: Patients scheduled to undergo oral and maxillofacial surgery under general anesthesia
Consent: Patients who have provided written informed consent after receiving a sufficient explanation regarding participation in this study
Key exclusion criteria
1.Individuals objectively judged to lack the capacity to give informed consent
2.Patients with cardiovascular diseases (including hypertension)
3.Pregnant women
4.Patients with an ASA physical status (ASA-PS) of 3 or higher
5.Patients with a Body Mass Index (BMI) of 30 kg/m2 or higher
6.Patients with a history of soybean or egg allergy
7.Patients who cannot or do not provide consent
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Manabe |
| Middle name | |
| Last name | Yozo |
Organization
Osaka Dental University
Division name
Department of Anesthesiology
Zip code
540-0008
Address
1-5-17 Otemae, Chuo-ku, Osaka
TEL
06-6910-1031
manabe-y@cc.osaka-dent.ac.jp
Public contact
Name of contact person
| 1st name | Kanoko |
| Middle name | |
| Last name | Yoshio |
Organization
Osaka Dental University
Division name
Department of Anesthesiology
Zip code
540-0008
Address
1-5-17 Otemae, Chuo-ku, Osaka
TEL
06-6910-1031
Homepage URL
aubergine.bokenashu7373@gmail.com
Sponsor or person
Institute
Osaka Dental University
Institute
Department
Personal name
Funding Source
Organization
Osaka Dental University
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
Osaka Dental University Ethics Committee
Address
8-1 Kuzuha-hanazonocho, Hirakata-shi, Osaka
Tel
072-864-3091
oduresearch@cc.osaka-dent.ac.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
大阪歯科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | 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
131
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
Completed
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 05 | Month | 31 | Day |
Other
Other related information
This trial registration was completed retrospectively due to an administrative oversight and an initial misunderstanding regarding the definition of clinical trials, following the protocol approved by our Institutional Review Board (IRB) prior to patient enrollment.
Management information
Registered date
| 2026 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071373
