UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039944 |
|---|---|
| Receipt number | R000045546 |
| Scientific Title | Intraoperative dexmedetomidine as an adjuvant to general anesthesia improves postoperative analgesia and quality of recovery. |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2022/03/30 15:34:35 |
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Basic information
Public title
Intraoperative dexmedetomidine as an adjuvant to general anesthesia improves postoperative analgesia and quality of recovery.
Acronym
Intraoperative dexmedetomidine as an adjuvant to general anesthesia improves postoperative analgesia and quality of recovery.
Scientific Title
Intraoperative dexmedetomidine as an adjuvant to general anesthesia improves postoperative analgesia and quality of recovery.
Scientific Title:Acronym
Intraoperative dexmedetomidine as an adjuvant to general anesthesia improves postoperative analgesia and quality of recovery.
Region
| Japan |
Condition
Condition
Postoperative analgesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Intraoperative dexmedetomidine as an adjuvant to general anesthesia improves postoperative analgesia and quality of recovery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Demonstrating that dexmedetomidine improves postoperative analgesia and quality of recovery on the 1st day after surgery using NRS scale and QoR40 score.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dexmedetomidine as an analgesic/Saline
Interventions/Control_2
Intraoperative administration only for about 4 hours
0.5 mcg /kg / hr
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
General anesthesia without epidural anesthesia
Key exclusion criteria
Patients with reduced cardiac function (low cardiac output, advanced valvular disease, advanced atrioventricular block), patients with reduced circulating blood volume, severe anemia, liver dysfunction, renal dysfunction, drug dependence, extubation in the operating room after surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamashita |
Organization
Kobe city medical center general hospital
Division name
department of anesthesiology
Zip code
650047
Address
Kobe
TEL
0783024321
cantateveritas@kcho.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | Yamashita |
| Last name | Yamashita |
Organization
Kobe city medical center general hospital
Division name
department of anesthesiology
Zip code
650047
Address
Kobe
TEL
0783024321
Homepage URL
cantateveritas@kcho.jp
Sponsor or person
Institute
Kobe city medical center general hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe city medical center general hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe city medical center general hospital
Address
Chuouku Minatojimaminamichou2-1-1,Kobe
Tel
0783024321
cantateveritas@kcho.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
神戸市立医療センター中央市民病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
64
Results
DEX group, compared with control group, showed the followings; 1) significantly smaller maximum NRS pain score at rest within 4 hours after returning to the HCU (mean of 2.4 (SD of 2.0) vs. 4.2 (1.7)); 2) significantly smaller NRS pain score at rest on the following morning (1.9 (1.4) vs. 3.1 (1.6)); 3) significantly smaller doses of patient-controlled analgesia (PCA) fentanyl and acetaminophen; 4) smaller doses of pentazocine and flurbiprofen; and 5) more QoR score (86 vs. 80).
Results date posted
| 2022 | Year | 03 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 22 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 25 | Day |
Last modified on
| 2022 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045546
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| Registered date | File name |
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