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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015028
Receipt No. 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

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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
Institute Tokyo Metropolitan Tama Medical Center
Institute
Department

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
URL(English) https://upload.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


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