UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053293 |
|---|---|
| Receipt number | R000060825 |
| Scientific Title | Comparison of effects of target-controlled infusion of remifentanil and sufentanil on intraoperative blood pressure variability during video assisted thoracic surgery |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2025/03/25 16:20:12 |
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Basic information
Public title
Comparison of effects of target-controlled infusion of remifentanil and sufentanil on intraoperative blood pressure variability during video assisted thoracic surgery
Acronym
The effects of sufentanil on video assisted thoracic surgery
Scientific Title
Comparison of effects of target-controlled infusion of remifentanil and sufentanil on intraoperative blood pressure variability during video assisted thoracic surgery
Scientific Title:Acronym
The effects of sufentanil on video assisted thoracic surgery
Region
| Asia(except Japan) |
Condition
Condition
IV general anesthesia for video assisted thoracic surgery
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of target-controlled infusion of remifentanil and sufentanil on intraoperative blood pressure variability during video assisted thoracic surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Average Real Variability (ARV) of mean arterial pressure
Key secondary outcomes
- Postoperative pain using visual analogue scale (VAS, 0-10): 30 min, 2 hours, 6 hours, 24 hours after the procedure
- The accumulated dose of pain killer: at 30 min, 2 hours, 6 hours, 24 hours after the procedure
- The satisfaction of postoperative pain management using visual analogue scale (VAS, 0-10): at 6 hours and 24 hours after surgery
- Postoperative nausea and vomiting: the accumulated dose of anti-emetic drugs for 24 hours after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the intervention group, intraoperative pain management is performed using target-controlled infusion of sufentanil.
Interventions/Control_2
In the intervention group, intraoperative pain management is performed using target-controlled infusion of remifentanil.
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
| 19 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- ASA (American Society of Anesthesiologists) class I-II
- Lung cancer
- VATS lobectomy
Key exclusion criteria
- Bilobectomy or pneumonectomy
- Bilateral procedure
- Chronic pain disease
- Regular use of analgesics or opioids
- Psychiatric disorder
- Regular use of psychotropic drugs
- Renal or hepatic failure
- A history of allergy to opioids or any other drug used in the study
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Jin-Woo |
| Middle name | |
| Last name | Park |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
TEL
82-31-787-7499
jinul8282@gmail.com
Public contact
Name of contact person
| 1st name | Jin-Woo |
| Middle name | |
| Last name | Park |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
TEL
82-31-787-7499
Homepage URL
jinul8282@gmail.com
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
Funding Source
Organization
Hanlim Pharmaceutical, Ltd.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seoul National University Bundang Hospital
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
Tel
82-31-787-8801
snubhirb@gmail.com
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
| 2024 | Year | 01 | Month | 15 | 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
72
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 08 | Day |
Last modified on
| 2025 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060825
