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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039582
Receipt No. 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

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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
Obsterics 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
Email 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
Email psdelico06@yahoo.co.jp

Sponsor
Institute Teikyo University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045112

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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