UMIN-CTR Clinical Trial

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