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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042780
Receipt No. R000048829
Scientific Title Impact of anesthetic induction with Etomidate, Thiopentone and Propofol on regional cerebral oxygenation: An observational study in patients with traumatic brain injury
Date of disclosure of the study information 2022/06/30
Last modified on 2020/12/17

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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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