UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005110 |
|---|---|
| Receipt number | R000006078 |
| Scientific Title | Measurement and simulation of the blood level of the fentanyl during anesthesia |
| Date of disclosure of the study information | 2011/02/21 |
| Last modified on | 2018/06/08 17:45:32 |
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Basic information
Public title
Measurement and simulation of the blood level of the fentanyl during anesthesia
Acronym
Measurement and simulation of the blood level of the fentanyl
Scientific Title
Measurement and simulation of the blood level of the fentanyl during anesthesia
Scientific Title:Acronym
Measurement and simulation of the blood level of the fentanyl
Region
| Japan |
Condition
Condition
Patients undergoing mastectomy and endoscopic prostatectomy under general anesthesia
Classification by specialty
| Breast surgery | Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the accuracy of the simulation by measuring the blood level of the fentanyl during general anesthesia
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the blood level of the fentanyl with that predicted by simulation and to confirm the accuracy of the simulation
Key secondary outcomes
To assess the postoperative analgesia with the blood level of the fentanyl
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Fentanyl is administered during anesthesia
Interventions/Control_2
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing mastectomy and endoscopic prostatectomy who met the criteria of the American Society of Anesthesiologists physical status of 1-2
Key exclusion criteria
ASA physical status >=3, Obesity (BMI>30), Height>=180cm, Weight>=80Kg
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihito Fujita |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Anesthesiology and Medical Crisis Management
Zip code
Address
1 Kawasumi Mizuho-cho Mizuho-ku, Nagoya, Japan
TEL
052-851-5511
fujitayoshihito@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihito Fujita |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Anesthesiology and Medical Crisis Management
Zip code
Address
1 Kawasumi Mizuho-cho Mizuho-ku Nagoya
TEL
052-851-5511
Homepage URL
fujitayoshihito@yahoo.co.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Physical and Analytical Chemistry, School of Pharmacy, Kinjo Gakuin University
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
名古屋市立大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://jaclinicalreports.springeropen.com/articles/10.1186/s40981-017-0097-2
Number of participants that the trial has enrolled
Results
Abstract
Background The accuracy of simulation predicted fentanyl concentration in different types of surgical procedure is not fully understood. We wished to estimate the effect of different types of surgical procedure on the accuracy of such simulations.
Findings Fifty patients who had undergone elective mastectomy or laparoscopic prostatectomy, American Society of Anesthesiologists physical status 1, 2, were enrolled. Anesthesia was maintained throughout surgery with sevoflurane and a bolus infusion of fentanyl. A maintenance infusion was administered with 8 mL kg h Ringer acetate solution from the start of anesthesia to completion of blood sampling. An infusion to compensate for blood loss was administered, one to two volumes of hydroxyethyl starch. A blood sample was drawn every 30 min during anesthesia. We measured the plasma concentration of fentanyl in 358 samples from 50 patients. The plasma concentration of fentanyl was correlated significantly with the simulated predicted fentanyl concentration, r 0.734, P 0.01, but 36.0 percent of all samples had a difference greater than 0.5 ng ml. Approximately 0.3 ng mL of a fixed bias was shown throughout mastectomy. During laparoscopic prostatectomy, the fixed bias gradually became negative from 0.3 to minus 0.3 ng mL as the sampling stage proceeded.
Conclusions The predicted concentration of fentanyl was significantly correlated with the plasma concentration of fentanyl, r 0.734. However, there were different patterns of a fixed bias between mastectomy and laparoscopic prostatectomy groups. We should pay attention to this tendency among different surgical procedures.
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
| 2010 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 20 | Day |
Last modified on
| 2018 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006078
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/02/06 | fenta_repository_data1.xlsx |
