UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022599
Receipt number R000026048
Scientific Title Infusion Rate of Rocuronium for Deep Neuromuscular Blockade
Date of disclosure of the study information 2016/06/03
Last modified on 2023/05/06 11:57:46

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Basic information

Public title

Infusion Rate of Rocuronium for Deep Neuromuscular Blockade

Acronym

Infusion Rate of Rocuronium for Deep Neuromuscular Blockade

Scientific Title

Infusion Rate of Rocuronium for Deep Neuromuscular Blockade

Scientific Title:Acronym

Infusion Rate of Rocuronium for Deep Neuromuscular Blockade

Region

Japan


Condition

Condition

Elective surgical patients

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Although previous studies showed that surgical conditions were improved with deep neuromuscular blockade (NMB), the infusion rate of rocuronium for deep NMB remains unclear. The purpose of this study is to evaluate the infusion rate of rocuronium to maintain deep NMB.

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Infusion rate of rocuronium to maintain the neuromuscular blockade at 1 to 5 of post tetanic count at adductor pollicis.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Initial dose of rocuronium: 0.6 mg/kg, Maintenance of anesthesia: propofol.

Interventions/Control_2

Initial dose of rocuronium: 0.6 mg/kg, Maintenance of anesthesia: desflurane.

Interventions/Control_3

Initial dose of rocuronium: 0.6 mg/kg, Maintenance of anesthesia: sevoflurane.

Interventions/Control_4

Initial dose of rocuronium: 0.9 mg/kg, Maintenance of anesthesia: propofol.

Interventions/Control_5

Initial dose of rocuronium: 0.9 mg/kg, Maintenance of anesthesia: sevoflurane.

Interventions/Control_6

Initial dose of rocuronium: 0.9 mg/kg, Maintenance of anesthesia: desflurane.

Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. Acquisition of written informed consent.
2. Elective surgical patients.
3. Age; 20 years old or more and less than 65 years old.
4. Duration of anesthesia; 1.5 to 5 hours.

Key exclusion criteria

1. American Society of Anesthesiologists criteria; 3 or more.
2. Pregnant patients.
3. Body mass index; 30 kg/m2 or more.
4. Body mass index; less than 18.5 kg/m2.
5. Severe renal dysfunction patients; serum creatinine exceeded reference value.
6. Hepatic dysfunction patients; serum transaminase more than 100 U/L.
7. Patients with metabolic disorder.
8. Patients with neuromuscular disorder.
9. Patients with dyspnea, airway stenosis, and/or bronchial asthma.
10. Patients with hypersensitivity for rocuronium or sugammadex.
11. Patients with atopic disease.
12. Patients with systemic allergic symptoms.
13. Taking antihistamine and/or antiallergic drugs for more than a month.
14. Taking calcium antagonists, anticonvulsant agents, aminoglycoside antibiotics, polypeptide antibiotics, and/or metronidazole.
15. Patients required management with hypothermia during surgery.
16. Difficulty with appropriate neuromuscular monitoring.
17. Emergency surgical patients.
18. Patients with life-threatening medical condition.

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Sunaga

Organization

Jikei University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan

TEL

03-3433-1111ext.4040

Email

hs-031@jikei.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Sunaga

Organization

Jikei University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan

TEL

03-3433-1111ext.4040

Homepage URL


Email

hs-031@jikei.ac.jp


Sponsor or person

Institute

Jikei University School of Medicine,
Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

Jikei University School of Medicine,
Department of Anesthesiology

Organization

Division

Category of Funding Organization

Other

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

東京慈恵会医科大学附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 06 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

Open public recruiting

Date of protocol fixation

2016 Year 04 Month 08 Day

Date of IRB

2016 Year 04 Month 08 Day

Anticipated trial start date

2016 Year 06 Month 03 Day

Last follow-up date

2027 Year 03 Month 31 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 06 Month 03 Day

Last modified on

2023 Year 05 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026048


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name