UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035415 |
|---|---|
| Receipt number | R000040269 |
| Scientific Title | Effects of monitoring of nociceptive levels during general anesthesia on postoperative complications |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2023/07/04 15:46:39 |
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Basic information
Public title
Effects of monitoring of nociceptive levels during general anesthesia on postoperative complications
Acronym
Nociceptive levels during general anesthesia and postoperative complications
Scientific Title
Effects of monitoring of nociceptive levels during general anesthesia on postoperative complications
Scientific Title:Acronym
Nociceptive levels during general anesthesia and postoperative complications
Region
| Japan |
Condition
Condition
Abdominal tumors and inflammatory diseases
Classification by specialty
| Gastrointestinal surgery | Anesthesiology | Operative medicine |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of anesthetic managements using the Nociceptive Response (NR) for monitoring nociceptive levels during surgery under general anesthesia on postoperative complications and C-reactive protein levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative C-reactive protein levels, and the incidence of postoperative complications within 1 month after surgery, using Clavien-Dindo Classification
Key secondary outcomes
Perioperative infectious responses
Perioperative pain states
Perioperative nociceptive levels
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Managements of general anesthesia, with the Nociceptive Response (NR) for assessment of intraoperative nociceptive levels, during surgery.
Interventions/Control_2
Managements of general anesthesia, without the Nociceptive Response (NR) for assessment of intraoperative nociceptive levels, during surgery.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing elective laparoscpic surgery
Key exclusion criteria
American Society of Anesthesiologists- Physical status (ASA-PS) III and above.
Preoperative C-reactive protein level in the blood over 0.3mg/dL.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Munetaka |
| Middle name | |
| Last name | Hirose |
Organization
Hyogo Medical University School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6392
mhirose@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Ogata |
Organization
Hyogo Medical University School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6392
Homepage URL
hi-ogata@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Hyogo Medical University
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel
0798-45-6066
rinri@hyo-med.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
兵庫医科大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | 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
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
| 2018 | Year | 12 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 30 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040269
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
