UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039872 |
|---|---|
| Receipt number | R000045472 |
| Scientific Title | Comparative study of iv esmolol,iv diltiazem, and iv lignocaine hydrochloride in attenuating pressure response to laryngoscopy and intubation |
| Date of disclosure of the study information | 2020/03/20 |
| Last modified on | 2020/03/18 23:58:15 |
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Basic information
Public title
Comparing three drugs for reducing heart rate and blood pressure during laryngoscopy andintubation
Acronym
Comparing three drugs for reducing heart rate and blood pressure during laryngoscopy andintubation
Scientific Title
Comparative study of iv esmolol,iv diltiazem, and iv lignocaine hydrochloride in attenuating pressure response to laryngoscopy and intubation
Scientific Title:Acronym
Comparative study of iv esmolol,iv diltiazem, and iv lignocaine hydrochloride in attenuating pressure response to laryngoscopy and intubation
Region
| Asia(except Japan) |
Condition
Condition
Not applicable
Classification by specialty
| Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparative evaluation of attenuation of hemodynamic changes in patients to laryngoscopy and tracheal intubation using intravenous esmolol, lidocaine, and diltiazem
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Expected to find the attenuation of hemodynamic changes in patients to laryngoscopy and tracheal intubation using intravenous esmolol, lidocaine, and diltiazem and observed at baseline, after drug administration, immediately after intubation, and at 1, 3, and 5 min after intubation.
Key secondary outcomes
Expected to ascertain the superiority of one drug over the other in suppressing sympathetic response to laryngoscopy and tracheal intubation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Medicine |
Interventions/Control_1
55 ASA I/II patients will receive injection Lignocaine 1.5mg/kg iv given 90 seconds before laryngoscopy
Interventions/Control_2
55 ASA I/II patients will receive injection esmolol 2mg/kg iv given 3 minutes before laryngoscopy
Interventions/Control_3
55 ASA I/II patients will receive injection diltiazem 0.2 mg/kg iv given 3 minutes before laryngoscopy
Interventions/Control_4
55 ASA I/II patients will receive injection normal saline 3 ml iv given 3 minutes before laryngoscopy
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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Key exclusion criteria
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Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Sathya |
| Middle name | |
| Last name | Narayanan K |
Organization
Government medical college,Haldwani
Division name
Department of anaesthesiology ,criticcal care , pain & palliative medicine
Zip code
263139
Address
Rampur road, haldwani 263139,uttarakhand , india
TEL
+919597447444
sathyavaan4444@gmail.com
Public contact
Name of contact person
| 1st name | Sathya |
| Middle name | |
| Last name | Narayanan K |
Organization
Government medical college,Haldwani
Division name
Department of anaesthesiology ,criticcal care , pain & palliative medicine
Zip code
263139
Address
Rampur road, haldwani 263139,uttarakhand , india
TEL
+919597447444
Homepage URL
sathyavaan4444@gmail.com
Sponsor or person
Institute
Government medical college,Haldwani
Institute
Department
Personal name
Funding Source
Organization
Government medical college,Haldwani
Government medical college,Haldwani
Department of anaesthesiology ,criticcal care , pain & palliative medicine
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
Government medical college,Haldwani
Address
Rampur road, haldwani 263139,uttarakhand , india
Tel
+919597447444
sathyavaan4444@gmail.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
| 2020 | Year | 03 | Month | 20 | 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
220
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
to be published in the journal
Date of the first journal publication of results
Baseline Characteristics
Heart rate , Blood pressure , Mean arterial pressure , Rate pressure products
Participant flow
Adverse events
No adverse effects noted
Outcome measures
it was observed that esmolol was superior in attenuating heart rate and diastolic blood pressure as compared to diltiazem and lignocaine while diltiazem was superior in attenuating systolic blood pressure as compared to esmolol and lignocaine .
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 11 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 11 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 18 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045472
