| CTRI Number |
CTRI/2018/05/014172 [Registered on: 29/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
10/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Drugs to reduce Heart rate and Blood pressure during Anaesthesia |
|
Scientific Title of Study
|
Comparison of Esmolol and Lignocaine in Attenuation of Stress Response to Laryngoscopy and Intubation |
| Trial Acronym |
ESMOTRIAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SONIA M LAL |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Sree Gokulam Medical College And Research Foundation |
| Address |
Department of Anaesthesiology
Sree Gokulam Medical College And Research Foundation
Venjaramoodu
Thiruvananthapuram
Kerala
695607
INDIA
Thiruvananthapuram
KERALA
695607
India |
| Phone |
04723041000 |
| Fax |
|
| Email |
sonnik1@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SONIA M LAL |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Sree Gokulam Medical College And Research Foundation |
| Address |
Department of Anaesthesiology
Sree Gokulam Medical College And Research Foundation
Venjaramoodu
Thiruvananthapuram
Kerala
695607
INDIA
Thiruvananthapuram
KERALA
695607
India |
| Phone |
04723041000 |
| Fax |
|
| Email |
sonnik1@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhu Velayudhen |
| Designation |
Associate Professor |
| Affiliation |
Sree Gokulam Medical College And Research Foundation |
| Address |
Department of Anaesthesiology
Sree Gokulam Medical College And Research Foundation
Venjaramoodu
Thiruvananthapuram
Kerala
695607
INDIA
Thiruvananthapuram
KERALA
695607
India |
| Phone |
04723041000 |
| Fax |
|
| Email |
drmadhuvelayuden@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Gokulam Medical College And Research Foundation
Venjaramoodu
Thiruvananthapuram
Kerala
695607
INDIA
|
|
|
Primary Sponsor
|
| Name |
Sree Gokulam Medical College And Research Foundation |
| Address |
Venjaramoodu
Thiruvananthapuram
Kerala
695607
INDIA
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sonia M Lal |
Assistant Professor
Department of Anaesthesiology
Sree Gokulam Medical College And Research Foundation
Venjaramoodu
Thiruvananthapuram
Kerala
695607
INDIA
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonia M Lal |
Sree Gokulam Medical College And Research Foundation |
Main Operation Theatre Complex,
Department of Anaesthesiology,
Venjaramoodu
Thiruvananthapuram
Kerala
695607
Thiruvananthapuram
KERALA |
9846242421
sonnik1@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sree Gokulam Medical College And Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Stress Response (Heart Rate , Blood Pressure), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ESMOLOL |
intravenous Esmolol 1.0 mg/kg (diluted to 0.5% solution) as slow bolus injection just after induction for attenuation of pressor response to laryngoscopy and intubation.
|
| Comparator Agent |
LIGNOCAINE |
intravenous Lignocaine without preservative 1.5 mg/kg ( 2% solution) just after induction for attenuation of pressor response to laryngoscopy and intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I, II
Mallampatti Class I or II
Age : 18-60 yrs
Weight : 40 – 90 kg
Elective non-cardiac surgery
|
|
| ExclusionCriteria |
| Details |
Heart rate <70/mt.
Basal systolic BP<100mm Hg
H/o of asthma, cardiac disease & presence of heart block.
ASA PS > II
Anticipated difficult intubation
Anxious or apprehensive patients
Intubation time more than 15 seconds
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevention of rise in Blood Pressure and Heart Rate due to laryngoscopy and intubation |
T0 : Baseline recording on entering the operating room.
T1 :Just before induction
T2 : During laryngoscopy and intubation
T3 :1 min after laryngoscopy
T4 : 3 min after laryngoscopy
T5: 5 min after laryngoscopy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of safety of Esmolol and Lignocaine administered ( monitoring for arrythmias) |
T0 : Baseline recording on entering the operating room.
T1 :Just before induction
T2 : During laryngoscopy and intubation
T3 :1 min after laryngoscopy
T4 : 3 min after laryngoscopy
T5: 5 min after laryngoscopy
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
26/09/2012 |
| Date of Study Completion (India) |
26/09/2013 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypertension and tachycardia occurring during laryngoscopy and intubation could be deleterious to certain patients.
The present study was designed to compare the effectiveness of Esmolol and Lignocaine in attenuating the stress response to laryngoscopy and intubation in 60 normal healthy patients of ASA grade I and II , of either sex , in the age group of 18-60 years for elective noncardiac surgery requiring general anaesthesia.
This was done by noting the pressor response variables namely Heart rate, Systolic blood pressure, Diastolic blood pressure and Mean arterial pressure.
The trends of these parameters were noted at frequent intervals in the first 8 minutes after induction of anaesthesia. There were no arrythmias.
The results were statistically analysed . Compared with the Lignocaine group, the attenuation of stress response variables were better in the Esmolol group.
Esmolol was found to be more effective than Lignocaine in controlling the stress response to larngoscopy and intubation. Esmolol 1 mg/kg was found to be safe and effective in controlling the pressor response to laryngoscopy and intubation.
|