UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011185 |
|---|---|
| Receipt number | R000013102 |
| Scientific Title | Comparison of intraoperative relatively high-dose and low-dose remifentanil for postoperative epidural analgesia after gynecological abdomonal surgery |
| Date of disclosure of the study information | 2013/07/13 |
| Last modified on | 2013/08/25 09:15:21 |
* 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
Comparison of intraoperative relatively high-dose and low-dose remifentanil for postoperative epidural analgesia after gynecological abdomonal surgery
Acronym
Intraoperative remifentanil for postoperative epidural analgesia
Scientific Title
Comparison of intraoperative relatively high-dose and low-dose remifentanil for postoperative epidural analgesia after gynecological abdomonal surgery
Scientific Title:Acronym
Intraoperative remifentanil for postoperative epidural analgesia
Region
| Japan |
Condition
Condition
gynecological abdominal surgery
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective was to compare the effect of intraoperative high-dose and low-dose remifentanil infusion on postoperative epidural analgesia started at the end of surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cumulative amount of local anesthetics at 48 h after surgery
Key secondary outcomes
pain intensity assessed with the Prince Henry pain scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
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 high-dose remifentanil group, while an end-tidal sevoflurane concentration was maintained at 1.2% throughout anaesthesia, a remifentanil infusion was started at a rate of 0.25 ug/kg/min and subsequently increased or decreased stepwise by 0.05 ug/kg/min increments to maintain systolic blood pressure within 20% of baseline values during surgery.
Interventions/Control_2
In the low-dose remifentanil group, while a remifentanil infusion was maintained at a rate of 0.1 ug/kg/min throughout anaesthesia, an end-tidal sevoflurane concentration was started at 2.0% and subsequently increased or decreased stepwise by 0.5% increments to maintain systolic blood pressure within 20% of baseline values during surgery.
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
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
patients undergo elective gynaecological abdominal surgery with lower abdominal incision below umbilicus
Key exclusion criteria
Patients were not excluded if they had diabetes, chronic pain, psychiatric illness, a preoperative use of opioid analgesics, a history of drugs or alcohol abuse, or were unable to use a patient-controlled analgesia (PCA) device. Patients were also excluded if there were any contraindications to epidural catheter placement, or if they refused epidural catheter placement.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamashita, Soichiro |
Organization
University of tsukuba
Division name
Department of Anesthesiology, Faculty of Medicine
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki 305-8575, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamashita, Soichiro |
Organization
University of tsukuba
Division name
Faculty of Medicine
Zip code
Address
TEL
Homepage URL
soichiyamashita@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of anesthesiology, Faculty of medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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 | 07 | Month | 13 | 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
| 2009 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 12 | Day |
Last modified on
| 2013 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013102
