UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014751 |
|---|---|
| Receipt number | 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 17:01:00 |
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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
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
suzuka333phoenix@yahoo.co.jp
Sponsor or person
Institute
Osaka City General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017149
