UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045343 |
|---|---|
| Receipt number | R000051777 |
| Scientific Title | Effects of two inhalation anesthetics (sevoflurane, desflurane) on ventilatory impairment induced by remifentanil; retrospective study |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2021/09/01 21:44:28 |
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Basic information
Public title
Effects of two inhalation anesthetics (sevoflurane, desflurane) on ventilatory impairment induced by remifentanil; retrospective study
Acronym
Effects of two inhalation anesthetics (sevoflurane, desflurane) on ventilatory impairment induced by remifentanil; retrospective study
Scientific Title
Effects of two inhalation anesthetics (sevoflurane, desflurane) on ventilatory impairment induced by remifentanil; retrospective study
Scientific Title:Acronym
Effects of two inhalation anesthetics (sevoflurane, desflurane) on ventilatory impairment induced by remifentanil; retrospective study
Region
| Japan |
Condition
Condition
Elderly patients undergoing femur fracture surgery under general anesthesia
Classification by specialty
| Orthopedics | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ventilatory impairment sometimes occurs when a supraglottic device is used to maintain the airway of a patient and remifentanil is administered. The difference in the incidence of ventilatory impairment is compared retrospectively between two inhalation anesthetics (sevoflurane, desflurane).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of ventilatory impairment during general anesthesia in appropriate patients
Key secondary outcomes
anesthetic use during ventilatory impairment
decreased percutaneous oxygen saturation
patient characteristics
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient undergoing surgery for a femoral fracture
Airway is secured with supraglottic devices.
Patients who were treated with peripheral nerve block such as femoral nerve block.
Key exclusion criteria
Tracheal intubation was performed due to preoperative aspiration, respiratory complications, or difficulty in airway managements.
Patients who cannot undergo nerve block because of coagulation abnormalities or local infection.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Kawakami |
Organization
Nagano municipal hospital
Division name
Division of anesthesia
Zip code
3818551
Address
1333-1 Tomitake Nagano, Nagano, Japan
TEL
0262951199
katsuhiro_kawakami@hospital.nagano.nagano.jp
Public contact
Name of contact person
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Kawakami |
Organization
Nagano municipal hospital
Division name
Division of anesthesia
Zip code
3818551
Address
1333-1 Tomitake Nagano, Nagano, Japan
TEL
0262951199
Homepage URL
katsuhiro_kawakami@hospital.nagano.nagano.jp
Sponsor or person
Institute
Nagano municipal hospital
Division of anesthesia
Institute
Department
Personal name
Funding Source
Organization
Nagano municipal hospital
Division of anesthesia
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
Nagano municipal hospital
Address
1333-1 Tomitake Nagano, Nagano, Japan
Tel
0262951199
privacy@hospital.nagano.nagano.jp
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
長野市民病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
patient characteristic
Use of Anesthetics
Incidence or frequency of ventilatory impairment
Decreased percutaneous oxygen saturation (< 90%)
Management information
Registered date
| 2021 | Year | 09 | Month | 01 | Day |
Last modified on
| 2021 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051777
