UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015028
Receipt number R000017456
Scientific Title Is profound muscle relaxation necessary for laparoscopic surgery?
Date of disclosure of the study information 2014/09/03
Last modified on 2019/01/09 06:35:19

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Basic information

Public title

Is profound muscle relaxation necessary for laparoscopic surgery?

Acronym

Is profound muscle relaxation necessary for laparoscopic surgery?

Scientific Title

Is profound muscle relaxation necessary for laparoscopic surgery?

Scientific Title:Acronym

Is profound muscle relaxation necessary for laparoscopic surgery?

Region

Japan


Condition

Condition

cholelithiasis

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare surgical conditions during laparoscopic cholecystectomy in patients with deep neuromuscular block and moderate block.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The proportion of overall excellent relaxation.
The patient's condition is described as overall excellent relaxation if all the scores obtained are 4. Surgical conditions are assessed by surgeons using a four-point surgical rating scale.

Key secondary outcomes

Mean surgical rating score, mean intraabdominal pressure, the proportion of operations completed at pneumoperitoneum 8 mmHg, the number of times of additional dosage of rocuronium in case of inadequate surgical conditions.


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

NO

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

General anesthesia is induced propofol 2mg/kg and remifentanil 0.5 microgram/kg/min 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 20 min intervals according to a four-point surgical rating scale. In case inadequate surgical conditions, intraabdominal pressure is increased to 12mmHg. If still inadequate, a bolus dose of rocuronium 0.2mg/kg is given. When gallbladder is removed, infusion of rocuronium is stopped.

Interventions/Control_2

General anesthesia is induced propofol 2mg/kg and remifentanil 0.5 microgram/kg/min 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 20 min intervals according to a four-point surgical rating scale. In case inadequate surgical conditions, intraabdominal pressure is increased to 12mmHg. If still inadequate, a bolus dose of rocuronium 0.2mg/kg is given. When gallbladder is removed, infusion of rocuronium is stopped.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients scheduled for elective laparoscopic cholecystectomy.

Key exclusion criteria

neuromuscular disease, allergy to medication to be used during anesthesia, significant liver or renal dysfunction, apoplexy, a body mass index of >30, inability to give informed consent.

Target sample size

88


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 or person

Institute

Tokyo Metropolitan Tama Medical Center

Institute

Department

Personal name



Funding Source

Organization

Tokyo Metropolitan Government

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



Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 03 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

2014 Year 09 Month 03 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 03 Day

Last follow-up date

2018 Year 01 Month 24 Day

Date of closure to data entry

2018 Year 01 Month 24 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 02 Day

Last modified on

2019 Year 01 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017456


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name