UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039582 |
|---|---|
| Receipt number | R000045112 |
| Scientific Title | Evaluation of the method to predict perioperative opioid requirement by pupillometry before anesthesia and surgery. |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2020/02/24 13:15:41 |
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Basic information
Public title
Can pupil diameter changes predict individual variability of opioid sensitivity?
Acronym
pupil diameter changes and opioid sensitivity.
Scientific Title
Evaluation of the method to predict perioperative opioid requirement by pupillometry before anesthesia and surgery.
Scientific Title:Acronym
Perioperative opioid requirement and pupillometry
Region
| Japan |
Condition
Condition
Patients undergoing laparoscopic hysterectomy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a method for predicting perioperative opioid requirement
Basic objectives2
Others
Basic objectives -Others
To evaluate the association of the percent decrease in the pupil diameter following a small dose fentanyl administered just before anesthesia with perioperative opioid consumption.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between the percent decrease in the pupil diameter following a small dose of fentanyl and remifentany consumption during surgery (normalized with ideal body weight and duration of anesthesia).
Association between the percent decrease in pupil diameter following a small dose of fentanyl and postoperative fentanyl consumption within 24 h after surgery (normalized with body weight).
Key secondary outcomes
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
We measure the pupil diameter before and after small dose of fentanyl just before induction of general anesthesia.
We adjust the doses of propofol and remifentanyl to maintain BIS value, blood pressure and heart rate within pre-determined ranges to provide general anesthesia during surgery.
We measure fentanyl consumption using an infusion pump with intravenous patient controlled- analgesia function until 24 h after surgery. We add rescue anti-nociceptive drugs according to a pre-determined protocol.
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients undergoing laparoscopic hysterectomy
Key exclusion criteria
Patients receiving regional anesthesia, taking opioids, having contraindication for drugs planned to use. Patients with diabetes mellitus, psychotic and neurological diseases. Patients taking beta blocking agents, anti-cholinergic agents, and anti-psychotic drugs.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tomio |
| Middle name | |
| Last name | Andoh |
Organization
Mizonokuchi Hospital, Teikyo University School of Medicine
Division name
Department of Anesthesiology
Zip code
213-8507
Address
5-1-1 Futako, Takatu-ku, Kawasaki
TEL
0448443333
psdelico06@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomio |
| Middle name | |
| Last name | Andoh |
Organization
Mizonokuchi Hospital, Teikyo University School of Medicine
Division name
Department of Anesthesiology
Zip code
213-8507
Address
5-1-1 Futako, Takatu-ku, Kawasaki
TEL
0448443333
Homepage URL
psdelico06@yahoo.co.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
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
Teikyo University Review Boad
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
Tel
03-3964-7256
turb-office@teikyo-u.ac.jp
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
| 2020 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 24 | Day |
Last modified on
| 2020 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045112
