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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042393
Receipt No. 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 2020/11/10

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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 Toru
Middle name
Last name Goyagi
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
Email tgoyagi@doc.med.akita-u.ac.jp

Public contact
Name of contact person
1st name Toru
Middle name
Last name Goyagi
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
Email tgoyagi@doc.med.akita-u.ac.jp

Sponsor
Institute Akita University
Institute
Department

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
Email 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
2020 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048301

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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