UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010464 |
|---|---|
| Receipt number | R000012229 |
| Scientific Title | Comparing the stress reaction and postoperative recovery in laparoscopic surgery between Remifentanil and Fentanyl |
| Date of disclosure of the study information | 2013/04/10 |
| Last modified on | 2015/07/30 10:05:30 |
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Basic information
Public title
Comparing the stress reaction and postoperative recovery in laparoscopic surgery between Remifentanil and Fentanyl
Acronym
Comparing the stress reaction and postoperative recovery in laparoscopic surgery between Remifentanil and Fentanyl
Scientific Title
Comparing the stress reaction and postoperative recovery in laparoscopic surgery between Remifentanil and Fentanyl
Scientific Title:Acronym
Comparing the stress reaction and postoperative recovery in laparoscopic surgery between Remifentanil and Fentanyl
Region
| Japan |
Condition
Condition
Patients scheduled for laparoscopic or retroperitoneoscopic renal surgery
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the intraoperative secretion of stress hormone, postoperative quality of recovery, and postoperative quality of life for laparoscopic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of recovery, of postoperative day 1
Quality of life, of one and three months after the surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Remifentanil group:
maintain anesthesia with propofol, remifentanil (0.0-0.5mcg/kg/min), fentanyl (1mcg/kg hourly), and rocuronium
Interventions/Control_2
Fentanyl group:
maintain anesthesia with propofol, fentanyl (1mcg/kg), and rocuronium
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA physical status 1 and 2 patients undergoing the patients laparoscopic or retroperitoneoscopic renal surgery
Key exclusion criteria
Patients with corticosteroid, antiemetic, opioid, or immunosuppressant use, severe liver or renal dysfunction, poor Japanese comprehension, or psychiatric disturbance
Pregnant or suspected pregnant patients
Huge amount of blood loss during the surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayako Asakura |
Organization
Yokohama City University
Division name
Department of Anesthesiology
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2918
anesthes@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Asakura |
Organization
Yokohama City University
Division name
Department of Anesthesiology
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2918
Homepage URL
anesthes@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 04 | Month | 10 | 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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 10 | Day |
Last modified on
| 2015 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012229
