UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055547 |
|---|---|
| Receipt number | R000063120 |
| Scientific Title | Effect of intraoperative sufentanil use on postoperative pain in patients undergoing ambulatory surgery under general anesthesia |
| Date of disclosure of the study information | 2024/12/15 |
| Last modified on | 2024/09/19 19:20:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of intraoperative sufentanil use on postoperative pain in patients undergoing ambulatory surgery under general anesthesia
Acronym
Sopas
Scientific Title
Effect of intraoperative sufentanil use on postoperative pain in patients undergoing ambulatory surgery under general anesthesia
Scientific Title:Acronym
Sopas
Region
| Asia(except Japan) |
Condition
Condition
intraoperative sufentanil , ambulatory surgery
Classification by specialty
| Oto-rhino-laryngology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the effects of intraoperative use of sufentanil versus remifentanil on postoperative pain and recovery in patients undergoing sinonasal surgery (endoscopic sinus surgery, septoturbinoplasty) under general anesthesia in an ambulatory surgery center.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The total dose of fentanyl administered (in micrograms) for postoperative analgesia.
Key secondary outcomes
Number of doses of analgesics administered for postoperative pain relief
Occurrence of nausea and vomiting postsurgery, and use of antiemetics
Postoperative shivering
Time from administration of reversal agent to extubation
Recovery room stay duration
Time spent in the surgery center on the day of surgery
Patient satisfaction with anesthesia management at discharge from the surgery center
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sufentanil
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients aged 19 years and older undergoing surgery under general anesthesia through the ambulatory surgery center on the day of surgery
Key exclusion criteria
Preexisting renal or hepatic dysfunction
Pregnant women
Patients with known drug hypersensitivity to propofol, remifentanil, or sufentanil
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Jiyoun |
| Middle name | |
| Last name | Lee |
Organization
Seoul National University Bundang Hospital
Division name
Aensthesia and Pain medicine
Zip code
13620
Address
82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
TEL
0317873640
heykiki1@hanmail.net
Public contact
Name of contact person
| 1st name | Jiyoun |
| Middle name | |
| Last name | Lee |
Organization
Seoul National University Bundang Hospital
Division name
Anesthesia and Pain Medicine
Zip code
13620
Address
82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
TEL
0317873640
Homepage URL
heykiki1@hanmail.net
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
Funding Source
Organization
BC World Pharma
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 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Tel
0317878801
heykiki1@hanmail.net
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 | 12 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 19 | 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 | 09 | Month | 19 | Day |
Last modified on
| 2024 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063120
