UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042393 |
|---|---|
| Receipt number | R000048301 |
| Scientific Title | Study on postoperative analgesia and delirium after lung surgery |
| Date of disclosure of the study information | 2020/11/09 |
| Last modified on | 2022/11/10 18:45:35 |
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Basic information
Public title
Study on postoperative analgesia and delirium after lung surgery
Acronym
Study on postoperative analgesia and delirium after lung surgery
Scientific Title
Study on postoperative analgesia and delirium after lung surgery
Scientific Title:Acronym
Study on postoperative analgesia and delirium after lung surgery
Region
| Japan |
Condition
Condition
Thoracoscopic and thoracotomy pulmonary resection, partial lung resection
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the analgesic effect of ESP block and postoperative delirium using Remimazolam in comparison with the case of epidural block and desflurane
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative rest, pain assessment during movement (VAS), time to use additional analgesics after awakening, frequency of use, postoperative delirium
Key secondary outcomes
postoperative nausea, vomiting, side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
1) Desflurane + ESP (D-ESP) group
After general anesthesia is introduced, the surgical position (lateral position) is taken, and then an ESP block is performed under ultrasound guidance (0.25% levobupivacaine 20 ml).
Place a catheter under the erector spinae muscles and start intermittent administration (0.25% levobupivacaine).
The catheter is removed in the morning 3 days after surgery.
During surgery, desflurane and remifentanil are used to maintain anesthesia.
Interventions/Control_2
2) Desflurane + epidural block (D-Epi) group
An epidural catheter is placed in the upper chest before the introduction of general anesthesia, and continuous administration is started at the same time as the start of surgery. (0.25% levobupivacaine 4ml / hr)
The catheter is removed in the morning 3 days after surgery.
During surgery, desflurane and remifentanil are used to maintain anesthesia.
Interventions/Control_3
3) Remimazolam + ESP (R-ESP) group
After general anesthesia is introduced, the surgical position (lateral position) is taken, and then an ESP block is performed under ultrasound guidance (0.25% levobupivacaine 20 ml).
Place a catheter under the erector spinae muscles and start intermittent administration (0.25% levobupivacaine).
The catheter is removed in the morning 3 days after surgery.
During surgery, anesthesia is maintained with remimazolam and remifentanil.
Interventions/Control_4
4) Remimazolam + epidural block (R-Epi) group
An epidural catheter is placed in the upper chest before the introduction of general anesthesia, and continuous administration is started at the same time as the start of surgery. (0.25% levobupivacaine 4ml / hr)
The catheter is removed in the morning 3 days after surgery.
During surgery, anesthesia is maintained with remimazolam and remifentanil.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing thoracoscopic or thoracotomy in the lateral decubitus position for lobectomy, segmental lung resection, and partial lung resection
Key exclusion criteria
Exclude cases that apply to any one of the following
1) ASA classification > 4
2) Patients with a history of hypersensitivity to the drugs used in this study
3) Patients who are judged to be inappropriate by the doctor responsible for the medical institution conducting the research
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Sunaga |
Organization
Akita University Graduate School of Medicine
Division name
Anesthesia and Intensive Care Medicine
Zip code
010-8543
Address
1-1-1, Hondo, Akita-city, Akita
TEL
018-884-6175
s.sunaga@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Sunaga |
Organization
Akita University Graduate School of Medicine
Division name
Anesthesia and Intensive Care Medicine
Zip code
010-8543
Address
1-1-1, Hondo, Akita-city, Akita,
TEL
018-884-6175
Homepage URL
s.sunaga@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Akita University
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
IRB
Address
1-1-1, Hondo, Akita-city, Akita,
Tel
018-884-6216
soken@hos.akita-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 09 | 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
| 2020 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2024 | 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
| 2020 | Year | 11 | Month | 09 | Day |
Last modified on
| 2022 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048301
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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