UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030677
Receipt number R000035023
Scientific Title Comparison of injection pain between original and generic rocuronium
Date of disclosure of the study information 2018/01/05
Last modified on 2021/04/09 16:04:20

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Basic information

Public title

Comparison of injection pain between original and generic rocuronium

Acronym

Comparison of original and generic rocuronium
on injection pain

Scientific Title

Comparison of injection pain between original and generic rocuronium

Scientific Title:Acronym

Comparison of original and generic rocuronium
on injection pain

Region

Japan


Condition

Condition

Patients undergoing operations under general anesthesia, not limited to specific diseases

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The incidence of rocuronium injection pain has been reported. It has been suggested that generic rocuronium, which has glycine as one of the buffer materials, can reduce injection pain on study in rats. Our objective is to compare injection pain caused by between original and generic rocuronium in patients undergoing operations under general anesthesia.

Basic objectives2

Others

Basic objectives -Others

To verify the efficacy and the degree of side reactions

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Movement of the extremities after injecting rocuronium
Perfusion index
Changes of vital signs

Key secondary outcomes

Efficacy and the degree of side reactions of rocuronium


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We inject generic rocuronium 0.9 mg/kg into a vein after induction of general anesthesia with propofol or thiamylal.

Interventions/Control_2

We inject original rocuronium 0.9 mg/kg into a vein after induction of general anesthesia with propofol or thiamylal.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who undergo operations under general anesthesia

Key exclusion criteria

Patient with allergy of rocuronium, propofol and thiamyral
Patients with neuromuscular disease
Obesity patients (BMI 35 or higher)

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunobu Takahashi

Organization

Sapporo Medical University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

S1 W17, Chuo-ku, Sapporo,Hokkaido, 060-8556, Japan

TEL

+81-11-611-2111

Email

takahashi.k@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazunobu Takahashi

Organization

Sapporo Medical University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

S1 W17, Chuo-ku, Sapporo,Hokkaido, 060-8556, Japan

TEL

+81-11-611-2111

Homepage URL


Email

takahashi.k@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2018 Year 01 Month 05 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s00540-020-02889-2

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s00540-020-02889-2

Number of participants that the trial has enrolled

40

Results

Generic rocuronium was considered more suitable than the original rocuronium for induction of anesthesia by propofol performed with a target-controlled infusion system.

Results date posted

2021 Year 04 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

class I or II patients as per American Society of Anesthesiologists

Participant flow

Based on computer-generated randomization charts, patients were randomly divided into two groups, generic rocuronium group (Group G) and original rocuronium group (Group O).

Adverse events

none

Outcome measures

The primary outcome was the total incidence of movement after administration of rocuronium.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 10 Month 12 Day

Date of IRB

2018 Year 01 Month 31 Day

Anticipated trial start date

2018 Year 02 Month 10 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 01 Month 04 Day

Last modified on

2021 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035023


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name