UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000039872
Receipt No. 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 (Ver. 1)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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 \x41\x67\x65\x20\x67\x72\x65\x61\x74\x65\x72\x20\x74\x68\x61\x6E\x20\x31\x38\x20\x79\x65\x61\x72\x73\x20\x20\x61\x6E\x64\x20\x65\x71\x75\x61\x6C\x20\x6F\x72\x20\x6C\x65\x73\x73\x65\x72\x20\x74\x68\x61\x6E\x20\x20\x36\x30\x20\x79\x65\x61\x72\x73\x20\x6F\x66\x20\x61\x67\x65\x3B\x20\x77\x65\x69\x67\x68\x74\x20\x65\x71\x75\x61\x6C\x20\x74\x6F\x20\x6F\x72\x20\x67\x72\x65\x61\x74\x65\x72\x20\x74\x68\x61\x6E\x20\x34\x30\x6B\x67\x20\x61\x6E\x64\x20\x65\x71\x75\x61\x6C\x20\x6F\x72\x20\x6C\x65\x73\x73\x65\x72\x20\x74\x68\x61\x6E\x20\x39\x30\x20\x6B\x67\x73\x20\x6F\x66\x20\x65\x69\x74\x68\x65\x72\x20\x73\x65\x78\x20\x20\x61\x6E\x64\x20\x42\x4D\x49\x20\x65\x71\x75\x61\x6C\x20\x74\x6F\x20\x6F\x72\x20\x67\x72\x65\x61\x74\x65\x72\x20\x74\x68\x61\x6E\x20\x31\x38\x2E\x35\x20\x20\x61\x6E\x64\x20\x65\x71\x75\x61\x6C\x20\x6F\x72\x20\x6C\x65\x73\x73\x65\x72\x20\x74\x68\x61\x6E\x20\x32\x34\x2E\x39\x20\x6F\x66\x20\x65\x69\x74\x68\x65\x72\x20\x73\x65\x78\x20\x41\x53\x41\x20\x70\x68\x79\x73\x69\x63\x61\x6C\x20\x73\x74\x61\x74\x75\x73\x20\xE2\x80\x93\x20\x0A\x47\x72\x61\x64\x65\x20\x49\x20\x61\x6E\x64\x20\x49\x49\x3B\x50\x61\x74\x69\x65\x6E\x74\x73\x20\x72\x65\x71\x75\x69\x72\x69\x6E\x67\x20\x67\x65\x6E\x65\x72\x61\x6C\x20\x41\x6E\x65\x73\x74\x68\x65\x73\x69\x61\x20\x61\x6E\x64\x20\x45\x6E\x64\x6F\x74\x72\x61\x63\x68\x65\x61\x6C\x20\x49\x6E\x74\x75\x62\x61\x74\x69\x6F\x6E\x2E
Key exclusion criteria \x50\x61\x74\x69\x65\x6E\x74\x20\x2F\x20\x67\x75\x61\x72\x64\x69\x61\x6E\x20\x72\x65\x66\x75\x73\x61\x6C\x20\x66\x6F\x72\x20\x63\x6F\x6E\x73\x65\x6E\x74\x3B\x41\x53\x41\x20\x67\x72\x61\x64\x65\x20\x49\x49\x49\x20\x61\x6E\x64\x20\x49\x56\x3B\x45\x6D\x65\x72\x67\x65\x6E\x63\x79\x20\x73\x75\x72\x67\x65\x72\x69\x65\x73\x3B\x50\x61\x74\x69\x65\x6E\x74\x73\x20\x62\x65\x74\x77\x65\x65\x6E\x20\x61\x67\x65\x20\x67\x72\x65\x61\x74\x65\x72\x20\x74\x68\x61\x6E\x20\x36\x30\x20\x79\x65\x61\x72\x73\x20\x61\x6E\x64\x20\x41\x67\x65\x20\x6C\x65\x73\x73\x65\x72\x20\x74\x68\x61\x6E\x20\x31\x38\x20\x79\x65\x61\x72\x73\x3B\x50\x61\x74\x69\x65\x6E\x74\x73\x20\x77\x65\x69\x67\x68\x69\x6E\x67\x20\x67\x72\x65\x61\x74\x65\x72\x20\x74\x68\x61\x6E\x20\x39\x30\x6B\x67\x20\x61\x6E\x64\x20\x6C\x65\x73\x73\x65\x72\x20\x74\x68\x61\x6E\x20\x34\x30\x6B\x67\x20\x20\x61\x6E\x64\x20\x42\x4D\x49\x20\x6C\x65\x73\x73\x65\x72\x20\x74\x68\x61\x6E\x20\x31\x38\x2E\x35\x20\x61\x6E\x64\x20\x20\x67\x72\x65\x61\x74\x65\x72\x20\x74\x68\x61\x6E\x20\x32\x34\x2E\x39\x3B\x50\x61\x74\x69\x65\x6E\x74\x73\x20\x73\x75\x73\x70\x65\x63\x74\x65\x64\x20\x74\x6F\x20\x68\x61\x76\x65\x20\x64\x69\x66\x66\x69\x63\x75\x6C\x74\x20\x74\x72\x61\x63\x68\x65\x61\x6C\x20\x69\x6E\x74\x75\x62\x61\x74\x69\x6F\x6E\x3B
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
Email 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
Email sathyavaan4444@gmail.com

Sponsor
Institute Government medical college,Haldwani



Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045472