UMIN-CTR Clinical Trial

Basic information
Public title	Impact of anesthetic induction with Etomidate, Thiopentone and Propofol on regional cerebral oxygenation: An observational study in patients with traumatic brain injury
Acronym	IETP-RCO2
Scientific Title	Impact of anesthetic induction with Etomidate, Thiopentone and Propofol on regional cerebral oxygenation: An observational study in patients with traumatic brain injury
Scientific Title:Acronym	IETP-RCO2
Region	Asia(except Japan)

Condition
Condition	Ongoing
Classification by specialty	Anesthesiology Neurosurgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study effect of anesthetic induction with Etomidate, Thiopentone and Propofol on rScO2 in patients undergoing emergency surgery for acute TBI
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement in prognosis of patient by stable anesthetic induction.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient of either gender aged 18 years and above undergoing emergency cranial surgery for acute TBI with moderate or severe GCS (12-3)
Key exclusion criteria	(i) No consent (ii) Pregnant patients (iii) Contraindication to study drugs (haemodynamically unstable patient, ASA 3,4 or 5) (iv) Patients with maxillofacial injuries (v) Patients with factors that will affect NIRS values (like underlying scalp haematoma or pneumocephalus) (vi) Airway contamination or likelihood of pulmonary aspiration (vii) Patients already intubated in casualty ward
Target sample size	90

Research contact person
Name of lead principal investigator	1st name KUNAL Middle name Last name KUMAR
Organization	NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES
Division name	NEUROANESTHESIA AND NEURO CRITICAL CARE
Zip code	560029
Address	NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES {NIMHANS}, HOSUR ROAD, BENGALURU, KARNATKA, INDIA
TEL	7018388348
Email	kunaal_kumar@yahoo.com

Public contact
Name of contact person	1st name KUNAL Middle name Last name KUMAR
Organization	NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES
Division name	NEUROANESTHESIA AND NEURO CRITICAL CARE
Zip code	560029
Address	NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES {NIMHANS}, HOSUR ROAD, BENGALURU, KARNATKA, I
TEL	7018388348
Homepage URL
Email	kunaal_kumar@yahoo.com

Sponsor
Institute	NIMHANS NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES
Institute
Department

Funding Source
Organization	ICMR INDIAN COUNCIL OF MEDICAL RESEARCH
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	INDIAN

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

IRB Contact (For public release)
Organization	NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES {NIMHANS}
Address	NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES {NIMHANS}, HOSUR ROAD, BENGALURU, KARNATKA, INDIA
Tel	7018388348
Email	kunaal_kumar@yahoo.com

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 06 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
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	Open public recruiting
Date of protocol fixation	2020 Year 01 Month 27 Day
Date of IRB	2020 Year 01 Month 27 Day
Anticipated trial start date	2020 Year 02 Month 06 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete	2021 Year 06 Month 30 Day
Date analysis concluded	2021 Year 11 Month 30 Day

Other
Other related information	This observational trial is still ongoing. Full results shall be evaluated by appropriate statistical analysis.

Management information
Registered date	2020 Year 12 Month 17 Day
Last modified on	2020 Year 12 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048829

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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