UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025194 |
|---|---|
| Receipt number | R000028983 |
| Scientific Title | Is deep neuromuscular block useful during laparoscopic gastrectomy? |
| Date of disclosure of the study information | 2016/12/09 |
| Last modified on | 2019/12/17 10:22:42 |
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Basic information
Public title
Is deep neuromuscular block useful during laparoscopic gastrectomy?
Acronym
Is deep neuromuscular block useful during laparoscopic gastrectomy?
Scientific Title
Is deep neuromuscular block useful during laparoscopic gastrectomy?
Scientific Title:Acronym
Is deep neuromuscular block useful during laparoscopic gastrectomy?
Region
| Japan |
Condition
Condition
stomach cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We hypothesized that deep neuromuscular block improves the quality of surgical conditions compared with moderate block during laparoscopic gastrectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of patients with a overall SRS of optimal conditions
Because I had registered the contents which were not the protocol that I submitted it to in an Ethical Review Board, I made modifications.
Key secondary outcomes
mean intraabdominal pressure, proportion of laparoscopies performed with an intra-abdominal pressure of 10 mmHg, the rate of change of modified abdominal girth in before and after pneumoperitoneum, the incidence of shoulder pain leaving an operating room and one day after surgery
Because I had registered the contents which were not the protocol that I submitted it to in an Ethical Review Board, I made modifications.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
All patients have inserted an epidural catheter before induction of general anesthesia. Standard monitoring is applied with bispectral index (BIS) monitoring. Neuromuscular monitoring is performed with TOF-Watch. General anesthesia is induced propofol and remifentanil IV. After calibration of the TOF-Watch, rocuronium 0.6mg/kg is injected to facilitate tracheal intubation. Anesthesia is maintained with IV infusion of propofol and remifentanil. Propofol dosing is such that BIS values remained within the range of 40-60. TOF measurement is made every 6 minutes during surgery. When TOF count is >2, a bolus dose of rocuronium 0.1mg/kg is administrated. Target TOF count is 1 to 2. During the laparoscopic procedure, the surgeon scored the surgical working conditions at 15 min intervals according to a five-point surgical rating scale(1=extremely poor conditions to 5=optimal conditions). Pneumoperitoneum is started at 10mmHg. If patients are moving during surgery, a bolus dose of rocuronium 0.2mg/kg is given. The SRS just after moving is 1( extremely poor conditions). In the case of inadequate surgical conditions, the intraabdominal pressure is increased to 12mmHg. If still inadequate, a bolus dose of rocuronium 0.2mg/kg is given. If subcutaneous emphysema occurs, the intraabdominal pressure decreases. Surgeons measure modified abdominal girth in before and after pneumoperitoneum.
Interventions/Control_2
All patients have inserted an epidural catheter before induction of general anesthesia. Standard monitoring is applied with bispectral index (BIS) monitoring. Neuromuscular monitoring is performed with TOF-Watch. General anesthesia is induced propofol and remifentanil IV. After calibration of the TOF-Watch, rocuronium 1.0mg/kg is injected to facilitate tracheal intubation. Anesthesia is maintained with IV infusion of propofol and remifentanil. Propofol dosing is such that BIS values remained within the range of 40-60. PTC measurement is made every 6 minutes during surgery. When PTC is >2, a bolus dose of rocuronium 0.2mg/kg is administrated. Target PTC is 0 to 2.
During the laparoscopic procedure, the surgeon scored the surgical working conditions at 15 min intervals according to a five-point surgical rating scale(1=extremely poor conditions to 5=optimal conditions). Pneumoperitoneum is started at 10mmHg. If patients are moving during surgery, a bolus dose of rocuronium 0.2mg/kg is given. The SRS just after moving is 1( extremely poor conditions). In the case of inadequate surgical conditions, the intraabdominal pressure is increased to 12mmHg. If still inadequate, a bolus dose of rocuronium 0.2mg/kg is given. If subcutaneous emphysema occurs, the intraabdominal pressure decreases. Surgeons measure modified abdominal girth in before and after pneumoperitoneum.
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 gastrectomy
Key exclusion criteria
neuromuscular disease, allergy to medication to be used during anesthesia, significant liver or renal dysfunction, apoplexy, contraindication for epidural anesthesia, inability to give informed consent
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaya Hojo |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Anaesthesia
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
ha_hi_hu_he_hojo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaya Hojo |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Anaesthesia
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
Homepage URL
ha_hi_hu_he_hojo@yahoo.co.jp
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan
Organization
Division
Category of Funding Organization
Local Government
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
東京都立多摩総合医療センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 09 | 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
| 2016 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 09 | Day |
Last modified on
| 2019 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028983
