UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047425 |
|---|---|
| Receipt number | R000054065 |
| Scientific Title | Measurement of opioid sensitivity by sympathetic response evoking threshold during sevoflurane anesthesia. |
| Date of disclosure of the study information | 2022/04/08 |
| Last modified on | 2026/02/09 13:44:38 |
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Basic information
Public title
Measurement of opioid sensitivity by sympathetic response evoking threshold during sevoflurane anesthesia.
Acronym
Measurement of opioid sensitivity by sympathetic response evoking threshold during sevoflurane anesthesia.
Scientific Title
Measurement of opioid sensitivity by sympathetic response evoking threshold during sevoflurane anesthesia.
Scientific Title:Acronym
Measurement of opioid sensitivity by sympathetic response evoking threshold during sevoflurane anesthesia.
Region
| Japan |
Condition
Condition
Elective surgery patient over 20 years old
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The validation for new index(MECK) using sympathetic response can be a indicator of the rate of change of systolic blood pressure (ROCBP) before and after skin incision during sevoflurane anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation coefficient between MECK and ROCBP
Key secondary outcomes
Compare correlation coefficient between MECK and ROCBP in our previous study which used propofol with correlation coefficient of this study
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who under go open surgery which require invasive blood pressure measurement during sevoflurane anesthesia.
Patients who are informed enough and presents the will of participation to this study by written form.
Key exclusion criteria
Patients with irregular R-R intervals on the electrocardiogram.
Patients who cannot measure invasive blood pressure in the radial artery.
Patients with severe blood circulation or neuropathy in the upper limbs.
Patients with severe stenosis or obstructive lesions of coronary arteries and cerebrovascular disease.
Patients with contraindicated use of remifentanil or rocuronium.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Saeki |
Organization
Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
734-8551
Address
1-2-3,Kasumi,Minami-ku,Hiroshima
TEL
81-082-256-5267
nsaeki@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Shorin |
Organization
Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
734-8551
Address
1-2-3,Kasumi,Minami-ku,Hiroshima
TEL
81-082-256-5267
Homepage URL
dshorin@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care, Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethical Committee of Hiroshima University
Address
1-2-3,Kasumi,Minami-ku,Hiroshima
Tel
81-082-257-5907
iryo-seisaku@office.hiroshima-u.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37993532/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37993532/
Number of participants that the trial has enrolled
30
Results
MECK can be used as a predictive index for ROCBP under 0.7 MAC sevoflurane anesthesia.
Results date posted
| 2026 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
30 adult patients who underwent laparotomy at Hiroshima University Hospital between April 2022 and February 2023. Included patients underwent general anesthesia with sevoflurane and required invasive arterial pressure measurement. Written informed consent was obtained from all patients prior to their participation.
Participant flow
To measure the MECK and ROCBP under the same conditions as in our previous study, the following procedure was used in the present study: prior to inducing anesthesia, an electrocardiogram sensors for monitoring were placed on each patient's chest, an oxygen saturation (SpO2) monitor (TL-271T; Nihon Kohden, Tokyo, Japan) on the left middle finger, a sensor of electroencephalogram monitor (GE Entropy Module; GE Healthcare UK Ltd., Buckinghamshire, UK) on the forehead, and a neuromuscular blockade monitoring device (E-NMT ; GE Healthcare UK Ltd., Buckinghamshire, UK) on the ulnar side of the forearm of the right hand. A dose of remifentanil was administered to achieve a predicted effect site concentration of 2 ng/mL based on Minto's pharmacokinetic/pharmacodynamic model19, after which anesthesia was induced with 5% sevoflurane. In each patient, after confirming loss of consciousness, 50 mg of rocuronium was administered, a 22 G needle was placed in the left radial artery to monitor arterial pressure, and endotracheal intubation was initiated. Loss of consciousness was defined by loss of eyelash reflex. Thereafter, sevoflurane was administered again to achieve an expiratory concentration of 0.7 minimum alveolar concentration (MAC) after correcting for age20.
After sympathetic excitation caused by intubation-related stimulation subsided and the expiratory concentration of sevoflurane stabilized, continuous measurement of vascular stiffness (K value, explained in the next section) was initiated. Electrocardiogram, arterial blood pressure, and PPG data were output to a personal computer from a bedside patient monitor (BSS-9800; Nihon Kohden, Tokyo, Japan). These data were used to calculate the K values in real time. Tetanic stimuli were delivered at 50 Hz for five seconds through a two-pole body surface electrode on the ulnar side of the right hand using an Innervator 252 (Fisher & Paykel Healthcare, Auckland, New Zealand). The initial stimulation intensity was 10 mA and the intensity was increased in 10 mA increments to a maximum of 80 mA. A sufficient interval was provided between each stimulation. After confirming that the K value had returned to the pre-stimulus state, subsequent stimulation was performed. The same expiratory concentration of sevoflurane (0.7 MAC) and predicted effect-site concentration of remifentanil (2 ng/mL) were maintained until skin incision. The ROCBP was measured.
Adverse events
none
Outcome measures
The primary outcome was the correlation coefficient between the MECK and ROCBP under sevoflurane anesthesia.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measure MECK and the rate of change of systolic blood pressure before and after skin incision under sevoflurane 0.7MAC and remifentanil 2ng/ml anesthesia.
Management information
Registered date
| 2022 | Year | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054065
