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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014751
Receipt No. R000017149
Scientific Title A comparison of effects on respiratory function of sugammadex and neostigmine in the reversal of moderate rocuronium-induced neuromuscular blockade
Date of disclosure of the study information 2014/08/03
Last modified on 2014/08/03

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Basic information
Public title A comparison of effects on respiratory function of sugammadex and neostigmine in the reversal of moderate rocuronium-induced neuromuscular blockade
Acronym A comparison of effects on respiratory function of sugammadex and neostigmine in the reversal of moderate rocuronium-induced neuromuscular blockade
Scientific Title A comparison of effects on respiratory function of sugammadex and neostigmine in the reversal of moderate rocuronium-induced neuromuscular blockade
Scientific Title:Acronym A comparison of effects on respiratory function of sugammadex and neostigmine in the reversal of moderate rocuronium-induced neuromuscular blockade
Region
Japan

Condition
Condition Patients undergoing laparoscopic intestinal surgery
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Sugammadex has been shown to reduce the risk of residual muscle relaxant and postoperative respiratory complications. An experimental study reported that sugammadex slightly reduces tidal volume and minute volume in the reversal of rocuronium-induced blockade, unlike neostigmine. However, this comparison has not been performed in human clinical trials. We therefore investigated changes in forced vital capacity (FVC) and forced expiratory volume in one second (FEV1.0) after administration of sugammadex and neostigmine in a random controlled trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in forced vital capacity after administration of sugammadex and neostigmine
Key secondary outcomes Changes in forced expiratory volume in one second after administration of sugammadex and neostigmine

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 neostigmine was given
Interventions/Control_2 sugammadex was given
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
100 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing laparoscopic intestinal surgery
Key exclusion criteria 1) asthma 2) arrhythmia 3) psychiatric disorders, and neuromuscular disease 4) ischemic heart disease 5)systlic blood pressure > 80 mmHg 6)Electrolyte abnormality
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Arashi
Organization Osaka City General Hospital
Division name Department of Anesthesiology
Zip code
Address 2-13-22 Miyakojimahondori, Miyakojima-ku, Osaka 534-0021, Japan
TEL 06-6929-1221
Email suzuka333phoenix@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Arashi
Organization Osaka City General Hospital
Division name Department of Anesthesiology
Zip code
Address 2-13-22 Miyakojimahondori, Miyakojima-ku, Osaka 534-0021, Japan
TEL 06-6929-1221
Homepage URL
Email suzuka333phoenix@yahoo.co.jp

Sponsor
Institute Osaka City General Hospital
Institute
Department

Funding Source
Organization Osaka City General Hospital
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
2014 Year 08 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 Enrolling by invitation
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 01 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
2014 Year 08 Month 03 Day
Last modified on
2014 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017149

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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