UMIN-CTR Clinical Trial

Basic information
Public title	A validation study of sedation in cataract surgery using low-concentration nitrous oxide anesthesia A crossover design
Acronym	A study on the sedative effect in cataract surgery using low-concentration nitrous oxide anesthesia
Scientific Title	A validation study of sedation in cataract surgery using low-concentration nitrous oxide anesthesia A crossover design
Scientific Title:Acronym	A study on the sedative effect in cataract surgery using low-concentration nitrous oxide anesthesia
Region	Japan

Condition
Condition	Cataract
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating the Sedative Effects of Low-Concentration nitrous oxide anesthesia in Cataract Surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bispectral Index
Key secondary outcomes	Heart rate, oxygen saturation, upper extremity systolic and diastolic blood pressure, subjective questionnaire

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Type of inhaled gas during surgery for both eyes cataract surgery Low-concentration nitrous oxide anesthesia in the first eye, oxygen only in the second eye
Interventions/Control_2	Type of inhaled gas during surgery for both eyes cataract surgery Oxygen only in the first eye, low-concentration nitrous oxide anesthesia in the second eye
Interventions/Control_3	Type of inhaled gas at surgery for both eyes cataract surgery Oxygen only for 1st eye, Oxygen only for 2nd eye
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	67 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Cataract patients who underwent consecutive binocular cataract surgeries
Key exclusion criteria	Patients with known neurological disorders such as epilepsy, patients taking antipsychotic drugs, patients with previous stroke, patients with implanted cardiac pacemakers, and patients with nasal obstruction disease
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kaori Middle name Last name Morii
Organization	Medical corporation Asagiri Hospital
Division name	opthalmology
Zip code	673-0852
Address	1120-2 Asagiridai, Akashi-shi, Hyogo, Japan
TEL	078-912-7575
Email	k-morii@asagiri-hp.or.jp

Public contact
Name of contact person	1st name Koutarou Middle name Last name Ishigami
Organization	Medical corporation Asagiri Hospital
Division name	Clinical Engineering Technician Office
Zip code	673-0852
Address	1120-2 Asagiridai, Akashi-shi, Hyogo, Japan
TEL	078-912-7575
Homepage URL
Email	koutarou19931010@yahoo.co.jp

Sponsor
Institute	Medical corporation Asagiri Hospital
Institute
Department

Funding Source
Organization	self-procurement Medical corporation Asagiri Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Corporation Yoshinokukai Asagiri Hospital Ethics Review Committee
Address	1120-2 Asagiridai, Akashi-shi, Hyogo, Japan
Tel	0778-912-7575
Email	asagiri@asagiri-hp.or.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	2022 Year 09 Month 30 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	30
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	2020 Year 08 Month 27 Day
Date of IRB	2021 Year 09 Month 11 Day
Anticipated trial start date	2021 Year 03 Month 05 Day
Last follow-up date	2021 Year 12 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 09 Month 30 Day
Last modified on	2022 Year 09 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055903