UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023479 |
|---|---|
| Receipt number | R000027036 |
| Scientific Title | Comparion of the infusion rate of rocuronium necessary for obtain adequate surgical muscle relaxation between before and during hepatectomy with Pringle maneuver. |
| Date of disclosure of the study information | 2016/08/08 |
| Last modified on | 2021/02/14 22:48:10 |
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Basic information
Public title
Comparion of the infusion rate of rocuronium necessary for obtain adequate surgical muscle relaxation between before and during hepatectomy with Pringle maneuver.
Acronym
Comparion of the infusion rate of rocuronium between before and during hepatectomy with Pringle maneuver.
Scientific Title
Comparion of the infusion rate of rocuronium necessary for obtain adequate surgical muscle relaxation between before and during hepatectomy with Pringle maneuver.
Scientific Title:Acronym
Comparion of the infusion rate of rocuronium between before and during hepatectomy with Pringle maneuver.
Region
| Japan |
Condition
Condition
Surgical patients requiring hepatectomy with Pringle maneuver
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate a continuous infusion rate of rocuronium necessary for obtain optimal muscle relaxation, before and during hepatectomy with Pringle maneuver.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
continuous infusion rate for obtain muscle relaxasion(before, during, and after Pringle maneuver)
Key secondary outcomes
measured blood concentration of rocuronium during stable state of optimalmuscle relaxation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We adjust a continuous rocuronium infusion rate to keep T1 twitch hight from 3 to 10% with acceleromyography on the adductor pollicis in response to electrical stimulation of the ulnar nerve, also keep T1 hight to the same level during a Pringle maneuver by changing an infusion rate of rocuronium.
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
1)ASA physical status 1~3
2)age=>20
3)total venous anesthesia with propofol
4)Operation time=>3hours
5)written informed consent was obtained from the patients before the surgery
Key exclusion criteria
excluded if any one of the following criteria applied:
1) probably pregnant
2) abnormal serum electrolytes (Na +, K +, or Cl-)
3) renal dysfunction (serum creatinine greater than 2.0 mg/dl)
4) liver dysfunction (ALT and/or AST beyond twice the normal range)
5) ICG15=>15%
6) Child-Pugh classification=>B
7) emaciation (body mass index (BMI) less than 17), obesity (BMI more than 30)
8) neuromuscular disorders,
9) a history of hypersensitive reaction to Rb,
10) a history of treatment with drugs known to interact with Rb, such as aminoglycoside antibiotics, anticonvulsants, formulation lithium, or magnesium
11) hypothermia during anesthesia
12) systemic allergy
13) inappropriate patients judged by physician-in-charge
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kajiura |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
3308503
Address
1-847, Amanuma-cho, Oomiya-ku, Saitama 330-8503, Japan
TEL
048-647-2111
kajiura-hki@umin.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Kajiura |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
3308503
Address
1-847, Amanuma-cho, Oomiya-ku, Saitama 330-8503, Japan
TEL
048-647-2111
Homepage URL
kajiura-hki@umin.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Jichi Medical University
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
Jichi medical university, Saitama medical center
Address
1-847, Amanuma-cho, Omiya-ku, Saitama-city, Saitama
Tel
0486472111
kaji-akira@jichi.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
| 2016 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/29704050/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/29704050/
Number of participants that the trial has enrolled
18
Results
The infusion rate of rocuronium before, during, and after the Pringle maneuver was 7.2
plus or minus 1.8, 4.2 plus or minus 1.4, and 4.7 plus or minus 1.5 mcg/kg/min (mean plus or minus SD), respectively. The rocuronium infusion rate during the Pringle maneuver was decreased about 40% compared to that before this maneuver, and that after completion of the Pringle maneuver was not recovered to that before the Pringle maneuver. The 25% recovery time was 20 plus or minus 7 min.
Results date posted
| 2021 | Year | 02 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Hepatectomy patients with Pringle maneuver
Participant flow
Obtained research consent before hepatectomy
Adverse events
none
Outcome measures
The infusion rate of rocuronium before, during, and after the Pringle maneuver
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 04 | Day |
Last modified on
| 2021 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027036
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/04/03 | 肝切臨床研究.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/07/28 | 患者データ2.xlsx |
