UMIN-CTR Clinical Trial

Basic information
Public title	The anesthesia management with remifentanil uses partial antagonist effect of pentazocine for mu opioid receptor
Acronym	The anesthesia management with remifentanil uses partial antagonist effect of pentazocine for mu opioid receptor
Scientific Title	The anesthesia management with remifentanil uses partial antagonist effect of pentazocine for mu opioid receptor
Scientific Title:Acronym	The anesthesia management with remifentanil uses partial antagonist effect of pentazocine for mu opioid receptor
Region	Japan

Condition
Condition	Patients undergoing general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of the partial antagonist effect of pentazocine in reducing respiratory depression induced by remifentanil.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The effect that pentazocine has on respiratory depression induced by remifentanil.
Key secondary outcomes	Side effects of pentazocine.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Use pentazocine.
Interventions/Control_2	Not use pentazocine.
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	1 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients scheduled for elective surgery requiring general anesthesia. ASA-PS 1-2
Key exclusion criteria	ASA-PS >=3 Tha patients who are diagnosised or suspected sleep apnea syndrome
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hiroto Middle name Last name Chikubu
Organization	Matsudo city general hospital
Division name	Anesthesiology
Zip code	2702252
Address	993-1,Sendabori,Matsudo-shi,Chiba
TEL	0477122511
Email	higuneko1@yahoo.co.jp

Public contact
Name of contact person	1st name Hiroto Middle name Last name Chikubu
Organization	Matsudo city general hospital
Division name	Anesthesiology
Zip code	2702252
Address	993-1,Sendabori,Matsudo-shi,Chiba
TEL	0477122511
Homepage URL
Email	higuneko1@yahoo.co.jp

Sponsor
Institute	Matsudo city general hospital Anesthesiology
Institute
Department

Funding Source
Organization	Nothing
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	Matsudo city hospital network Institutional review board
Address	993-1,Sendabori,Matsudo-shi,Chiba
Tel	0477122511
Email	higuneko1@yahoo.co.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 01 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	10
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	Terminated
Date of protocol fixation	2019 Year 11 Month 01 Day
Date of IRB	2020 Year 01 Month 10 Day
Anticipated trial start date	2020 Year 01 Month 10 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry	2020 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 09 Day
Last modified on	2021 Year 01 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044594