UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049262 |
|---|---|
| Receipt number | R000055950 |
| Scientific Title | Comparison of analgesic level index between nociceptive stimulation monitor devices - A prospective observational study |
| Date of disclosure of the study information | 2022/10/19 |
| Last modified on | 2024/04/02 14:09:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison between devices of 'pain' monitors
Acronym
Comparison between devices of 'pain' monitors
Scientific Title
Comparison of analgesic level index between nociceptive stimulation monitor devices
- A prospective observational study
Scientific Title:Acronym
Comparison of analgesic level index between nociceptive stimulation monitor devices
- A prospective observational study
Region
| Japan |
Condition
Condition
osteoarthritis of the knee / spinal degenerative disease / cerebral aneurysm / brain tumor / uterine myoma / ovarian tumor / labor epidural analgesia
Classification by specialty
| Obstetrics and Gynecology | Orthopedics | Anesthesiology |
| Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The three elements of anesthesia are sedation, analgesia, and muscle relaxation. Of these three elements, reliable monitors have been established for sedation and muscle relaxation, but evaluation of analgesia has been difficult because patients sleeping under general anesthesia cannot complain of pain themselves, and the development of monitors has been slow. Until now, pain has been judged subjectively based on the experience and knowledge of anesthesiologists based on changes in circulatory dynamics such as heart rate and blood pressure, but in recent years, several nociceptive stimulation monitors (nociceptive stimulation/analgesia balance monitors) that display objective indicators by combining various parameters or using special algorithms have begun to be developed.
HFVI (High Frequency Variability Index; Masimo Japan Corporation/Heiwa Bussan Corporation) quantifies autonomic parasympathetic nerve activity from heart rate variability and noninvasively and continuously monitors stress on the patient.
NoL (Nociception Level Index) quantifies nociceptive stimuli obtained by reading pulse, skin temperature, and other information with the fingertip probe of the PMD-200 (Medasense, Inc.), also noninvasively and continuously. With the advent of these devices, objective assessment of nociceptive stimulation (including pain) may become possible. It has been suggested that anesthesia management using these monitors as indicators may reduce intraoperative narcotic use and may even reduce postoperative pain.
Although differences in measurement accuracy between monitor models have always been a matter of debate and clinical question in clinical practice, there have been no reports comparing nociceptive stimulus measurement models at this point. In this study, HFVI and NoL values were simultaneously measured in the same patient, and the trends in the measured values and measurement accuracy were examined.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Concordance rate between HFVI and NoL values
Key secondary outcomes
1) Correlation between CRP level on the first postoperative day and intraoperative HFVI and NoL values
2) Relationship between pain at the time of exit operation theater and HFVI and NoL values at that time
3) Rate of change in HFVI or NoL values after the start of insufflation in laparoscopic surgery
4) Changes in HFVI or NoL values for tourniquet pain in total knee arthroplasty
5) Rate of change of HFVI and NoL values for motor evoked potential measurements
6) Changes in HFVI and NoL values during cesarean section and labor epidural analgesia
7) Rate of change of HFVI or NoL values during insufflation and low head position
8) Change in NoL values of the shunt side finger in patients undergoing maintenance hemodialysis with a forearm shunt and the rate of concordance with HFVI.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The following patients undergoing surgery at Nara Medical University Hospital
Laparoscopic gynecological surgery (myomectomy, total hysterectomy, ovarian tumor removal, ovarian tumor enucleation)
Total knee arthroplasty
Spine surgery (spinal fusion, vertebroplasty)
Neurosurgery
Cesarean section
Patients undergoing scheduled surgery while on maintenance dialysis using a forearm shunt
Pregnant women who are scheduled to have labor epidural analgesia at Nara Medical University Hospital
(1) Patients who have given written consent of their own free will to participate in this study after receiving sufficient explanation and with full understanding
(2) Patients who are 18 years of age or older at the time of obtaining consent.
Key exclusion criteria
1) Patients with known arrhythmia
2) Patients with cardiac pacemakers
3) Patients after heart transplantation
4) Patients taking anticholinergic drugs such as atropine that affect the sinus node
5) Patients with missing fingers
6) Patients with Raynaud's symptoms
7) Other patients who are deemed inappropriate by the principal investigator or principal study investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Tanaka |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0742-46-6001
nobuhirotanaka@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Tanaka |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0742-46-6001
Homepage URL
nobuhirotanaka@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Nara Medical University Ethics Committee
Address
840 Shijo-cho, Kashihara, Nara, Japan
Tel
0744-22-3051
ino_rinri@naramed-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 | 10 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 21 | 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
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
observational study(prospective)
Management information
Registered date
| 2022 | Year | 10 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055950
