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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025194
Receipt No. R000028983
Scientific Title Is deep neuromuscular block useful during laparoscopic gastrectomy?
Date of disclosure of the study information 2016/12/09
Last modified on 2016/12/15

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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
Email 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
Email ha_hi_hu_he_hojo@yahoo.co.jp

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Institute
Department

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
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 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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 09 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
2016 Year 12 Month 09 Day
Last modified on
2016 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028983

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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