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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004522
Receipt No. R000005399
Scientific Title Prevention of residual neuromuscular blockade with sugammadex in patients received general anesthesia
Date of disclosure of the study information 2010/11/08
Last modified on 2011/05/09

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Basic information
Public title Prevention of residual neuromuscular blockade with sugammadex in patients received general anesthesia
Acronym Prevention of residual neuromuscular blockade with sugammadex
Scientific Title Prevention of residual neuromuscular blockade with sugammadex in patients received general anesthesia
Scientific Title:Acronym Prevention of residual neuromuscular blockade with sugammadex
Region
Japan

Condition
Condition Diseases which need operation under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is pointed out when the recovery of neuromuscular function is not enough after surgery, serious respiratory disorders such as oxygen desaturation will emerge at a high rate. Our previous multicenter study found the incidence of residual neuromuscular blockade in 22% of patients after general anesthesia. In this study we investigate the incidence of residual neuromuscular blockade after administration of sugammadex for reversal of neuromuscular blockade.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of patients whose TOF ratio <0.9 after tracheal extubation
Key secondary outcomes 1. Existence or nonexistence of pulmonary or other complication after surgery
2. Total rocuronium dose
3. Time from extubation to measurement of TOF ratio
4. Time from latest rocuronium use to extubation
5. Time from administration of sugammadex to extubation
6. The difference of TOF ratio among the ages and the anesthetic managements

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1. Induction and maintenance of anesthesia is done with anesthetics and analgesics which are appropriate for the surgical patients' conditions. Either inhalational anesthesia or TIVA is allowed.
2. Tracheal intubation is done after adequate dose of rocronium is injected.
3. Intraoperative rocuronium useage is determined by the anesthesiologist.
4. After surgery, recovery of neuromuscular blockade is done by intravenous administration of sugammadex. The dose is 2mg/kg after confirmation of spontaneous breathing or 4mg/kg before confirmation of spontaneous breathing.
5. After confirmation of recovery from neuromuscular blockade subjectively by respiration or muscular strengh, tracheal extubation is done.
6. After extubation and the patients are stable, TOF ratio at the thumb is measured by neuromuscular monitor(TOF-Watch) giving TOF stimulation(50mA) to ulnar nerve at fifteen seconds interval. When the difference of two data is over 10%, the measuring repeats until four mesuring is done. The measuring is done with hand adaptor.
7. When the TOF ratio<0.9, the reversal with sugammadex is considered once agein and the respiratory condition is checkd. When the reversal is done once again, another TOF ratio is measured.
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients, aged 20 or over (ASA phisical status 1-3) and who is operated under general anesthesia using rocuronium as neuromuscular blocking agent and sugammadex as neuromuscular reversal agent.
Key exclusion criteria Patients who have a history of hypersensitivity to rocuronium and bromide.
Patients who have a history of hypersensitivity to sugammadex.
Patients who have myasthenia gravis and myasthenic syndrome.
Target sample size 25

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Itsuo Nakatsuka
Organization Keio University Hospital
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Keio University Hospital
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
Homepage URL
Email

Sponsor
Institute Tokyo Neuromuscular Meeting
Institute
Department

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
2010 Year 11 Month 08 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
2010 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 08 Day
Last modified on
2011 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005399

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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