UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042780 |
|---|---|
| Receipt number | 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 | 2024/06/19 15:30:05 |
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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
Completed in December 2021
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
115
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
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
kunaal_kumar@yahoo.com
Sponsor or person
Institute
NIMHANS
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES
Institute
Department
Personal name
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
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
https://journals.lww.com/joacp/fulltext/9900/impact_of_anesthetic_induction_with_etomidate,.109.aspx
Publication of results
Unpublished
Result
URL related to results and publications
https://journals.lww.com/joacp/fulltext/9900/impact_of_anesthetic_induction_with_etomidate,.109.aspx
Number of participants that the trial has enrolled
115
Results
115
Results date posted
| 2024 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 08 | Day |
Baseline Characteristics
The total number of patients recruited was 116, of which 115 patients were included in the final analysis. Over the studied period, 32, 33, and 50 patients received thiopentone (Group 1), propofol (Group 2), and etomidate (Group 3), respectively [Figure 1]. The baseline demographics and the variables affecting rScO2, such as region of the injury, hemoglobin levels, SpO2, and HR, across the three groups were comparable, except for MAP. Also, between the groups, a significant difference was noted in the bilateral baseline rScO2.
Participant flow
good
Adverse events
On observing the number of patients who got extubated on table immediately after the surgery, a total of 57 patients were extubated, with the observed rate of extubation being 54% (27/50), 48% (16/33), and 43% (14/32) in etomidate, propofol, and thiopentone groups, respectively. Although the percentage of extubation in etomidate group was highest, the intergroup difference was insignificant
Outcome measures
At 24 h after anesthetic induction, an insignificant decrease in median serum cortisol levels was observed in the thiopentone (P = 0.364) and etomidate (P = 0.332) groups, whereas the propofol group revealed a statistically significant increase in serum cortisol levels after surgery (P = 0.004) [Table 3]. On pairwise intergroup comparison, a significant difference was observed in the changes in serum cortisol levels between the etomidate and propofol groups (P = 0.006), but it was comparable between thiopentone and etomidate (P = 0.184)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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 | 12 | Month | 16 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
This observational trial has now been completed. The statistical analysis was done with R-software.
Management information
Registered date
| 2020 | Year | 12 | Month | 17 | Day |
Last modified on
| 2024 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048829
