UMIN-CTR Clinical Trial

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

stomach cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Tokyo Metropolitan Tama Medical Center

Institute

Department

Personal name

Organization

Tokyo Metropolitan

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京都立多摩総合医療センター(東京都)

Date of disclosure of the study information

2016

Year

12

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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