UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019520 |
|---|---|
| Receipt number | R000022577 |
| Scientific Title | Examination about anesthesia method for laparoscopic inguinal hernia repair |
| Date of disclosure of the study information | 2015/10/29 |
| Last modified on | 2016/02/23 22:07:09 |
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Basic information
Public title
Examination about anesthesia method for laparoscopic inguinal hernia repair
Acronym
Examination about muscle relaxation status for laparoscopic inguinal hernia repair
Scientific Title
Examination about anesthesia method for laparoscopic inguinal hernia repair
Scientific Title:Acronym
Examination about muscle relaxation status for laparoscopic inguinal hernia repair
Region
| Japan |
Condition
Condition
Inguinal hernia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Laparoscopic inguinal hernia repair belongs to the group of short stay operation fee, and flat rate is applied regardless of hospitalization days and anesthesia method. In laparoscopic surgery, use of sufficient neuromuscular blocking agents reduces the occurrence of unacceptable surgical conditions. But if we use as much amount of muscle relaxants as for deep muscle relaxation, we need to administer expensive drug for muscle recovery. We try to examine if surgeons can undergo hernia repair with comfortable condition under even moderate muscle relaxation. We compared surgical conditions and total amount of costs for anesthesia during laparoscopic hernia repair between patients with deep and moderate muscular block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surgical space condition that are assessed by surgeons using a four point scale
Key secondary outcomes
Total amount of costs for general anesthesia
Postoperative pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
General anesthesia is indused with propofol 1-1.5mg/kg and remifentanil 0.2-0.3microgram/kg/min IV. After calibration of the TOF monitor, rocuronium 0.6mg/kg is injected to facilitate tracheal intubation. Anesthesia is maintained with sevoflurane and remifentanil, and rocuronium. TOF measurement is made every 5 minutes during surgery. When TOF count is >2, dose of rocuronium is increased by 0.1mg/kg/hr. When TOF count is 0, dose of rocuronium is decreased by 0.05mg/kg/hr. Target TOF count is 1. When peritoneum is closed, infusion of rocuronium is stopped. After the surgery, neostigmine is infused as neuromuscular antagonist. The surgeon scored the surgical working conditions according to the four-point rating scale. (moderate muscle relaxation group)
Interventions/Control_2
General anesthesia is indused with propofol 1-1.5mg/kg and remifentanil 0.2-0.3microgram/kg/min IV. After calibration of the TOF monitor, rocuronium 0.6mg/kg is injected to facilitate tracheal intubation. Anesthesia is maintained with sevoflurane and remifentanil, and rocuronium. PTC measurement is made every 5 minutes during surgery. When PTC count is >3, dose of rocuronium is increased by 0.1mg/kg/hr. When PTC count is 0, dose of rocuronium is decreased by 0.1mg/kg/hr. Target PTC count is 1-2. When peritoneum is closed, infusion of rocuronium is stopped. After the surgery, sugammadex is infused as neuromuscular reversal. The surgeon scored the surgical working conditions according to the four-point rating scale. (deep muscle relaxation group)
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
Patients scheduled for elective laparoscopic inguinal hernia repair
Key exclusion criteria
ASA physical status over three
Neuromuscular disease, allergy to medication to be used during anesthesia, significant liver or renal dysfunction
The patient who can't use of the atropine and neostigmine
The patient who undergoes other operations at the same time
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoko Shimizu |
Organization
Sumitomo Hospital
Division name
Department of Anesthesiology
Zip code
Address
5-3-20 Nakanoshima, kita-ku, osaka-city, Osaka, Japan
TEL
06-6443-1261
m1294620@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoko Shimizu |
Organization
Sumitomo Hospital
Division name
Department of Anesthesiology
Zip code
Address
5-3-20 Nakanoshima, kita-ku, osaka-city, Osaka, Japan
TEL
06-6443-1261
Homepage URL
m1294620@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Sumitomo Hospital
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
Address
Tel
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
| 2015 | Year | 10 | Month | 29 | 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
| 2015 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 23 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 23 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 23 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 27 | Day |
Last modified on
| 2016 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022577
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