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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035415
Receipt No. 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 2018/12/30

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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 malignant tumor
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
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of postoperative complications within 1 month after surgery, using Clavien-Dindo Classification
Key secondary outcomes Perioperative infectious responses(C-reactive protein, Cytokines)
Perioperative pain states
Perioperative nociceptive levels
Recurrence of malignant tumor

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 for abdominal malignant tumor
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 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Munetaka Hirose
Organization Hyogo College of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6392
Email mhirose@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Ogata
Organization Hyogo College of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6392
Homepage URL
Email hi-ogata@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 30 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
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
2018 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040269

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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