FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096295 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 21/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effects of Lidocaine vs Esmolol in reducing the variations in Blood pressure, Pulse Rate and Oxygen Saturation during laryngoscopy and endotracheal intubation in patients who are undergoing laparoscopic surgeries 
Scientific Title of Study   Comparison of efficacy between Esmolol IV vs Lidocaine IV in attenuation of haemodynamic stress response during laryngoscopy and endotacheal intubation in laparoscopic surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anupam B Balawan 
Designation  Resident Doctor 
Affiliation  Smt. Bhikiben Kanjibhai shah Medical Institute & Research Centre,  
Address  2nd Floor, Dept of anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research centre, Sumandeep Vidyapeeth, Piparia, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9916629916  
Fax    
Email  anupambalawan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kalpesh Patil 
Designation  Associate Professor 
Affiliation  Smt. Bhikiben Kanjibhai shah Medical Institute & Research Centre,  
Address  2nd Floor, Dept of anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research centre, Sumandeep Vidyapeeth, Piparia, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  7058308703  
Fax    
Email  drkalpeshpatil86@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kalpesh Patil 
Designation  Associate Professor 
Affiliation  Smt. Bhikiben Kanjibhai shah Medical Institute & Research Centre,  
Address  2nd Floor, Dept of anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research centre, Sumandeep Vidyapeeth, Piparia, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  7058308703  
Fax    
Email  drkalpeshpatil86@gmail.com  
 
Source of Monetary or Material Support  
Smt. Bhikiben Kanjibhai shah Medical Institute & Research Centre, Piparia, Vadodara, Gujarat - 391760 
 
Primary Sponsor  
Name  Smt. Bhikiben Kanjibhai shah Medical Institute & Research Centre,  
Address  Piparia, Vadodara, Gujarat - 391760 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kalpesh Patil  Dept of anaesthesiology,Smt. Bhikiben Kanjibhai shah Medical Institute & Research Centre,   Smt. Bhikiben Kanjibhai shah Medical Institute & Research Centre, Sumandeep Vidyapeeth, piparia, Vadodara, Gujarat - 391760
Vadodara
GUJARAT 
7058308703

drkalpeshpatil86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K352||Acute appendicitis with generalized peritonitis, (2) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (3) ICD-10 Condition: K358||Other and unspecified acute appendicitis, (4) ICD-10 Condition: K36||Other appendicitis, (5) ICD-10 Condition: K37||Unspecified appendicitis, (6) ICD-10 Condition: K389||Disease of appendix, unspecified, (7) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (8) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (9) ICD-10 Condition: K403||Unilateral inguinal hernia, with obstruction, without gangrene, (10) ICD-10 Condition: K403||Unilateral inguinal hernia, with obstruction, without gangrene, (11) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (12) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (13) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (14) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (15) ICD-10 Condition: K803||Calculus of bile duct with cholangitis, (16) ICD-10 Condition: K804||Calculus of bile duct with cholecystitis, (17) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (18) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (19) ICD-10 Condition: K808||Other cholelithiasis, (20) ICD-10 Condition: K810||Acute cholecystitis, (21) ICD-10 Condition: K811||Chronic cholecystitis, (22) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis, (23) ICD-10 Condition: K819||Cholecystitis, unspecified, (24) ICD-10 Condition: K822||Perforation of gallbladder, (25) ICD-10 Condition: K820||Obstruction of gallbladder, (26) ICD-10 Condition: K821||Hydrops of gallbladder, (27) ICD-10 Condition: K823||Fistula of gallbladder, (28) ICD-10 Condition: K828||Other specified diseases of gallbladder, (29) ICD-10 Condition: K829||Disease of gallbladder, unspecified, (30) ICD-10 Condition: N430||Encysted hydrocele, (31) ICD-10 Condition: N431||Infected hydrocele, (32) ICD-10 Condition: N432||Other hydrocele, (33) ICD-10 Condition: E040||Nontoxic diffuse goiter, (34) ICD-10 Condition: E042||Nontoxic multinodular goiter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inj Esmolol 2 mg/kg  Inj Esmolol 2 mg/kg IV given 3 minutes prior to laryngoscopy and endotracheal intubation 
Intervention  Inj Lidocainie 2 mg/kg  Inj Lidocaine 2 mg/kg IV is given 3 minutes prior to larngoscopy and endotracheal intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA
1.Patients willing to sign informed consent
2.Male or Female patients between 18 to 60 years of age
3.Patients belonging to American Society of Anaesthesiologists(ASA) physical status I & II
4.Patients posted for elective laparoscopic surgeries under general anaesthesia.
 
 
ExclusionCriteria 
Details  1.Patients unwilling to participate in study.
2.Patients with Body Mass Index more than 29 Kg per metre square
3.Patients with cerebrovascular diseases, hepatic and/or renal diseases
4.Psychiatric patients
5.Pregnancy and lactating women
6.Patients belonging to American Society of Anaesthesiologists (ASA) III and above.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Changes in Systolic and Diastolic Blood Pressures, Pulse Rate, Oxygen Saturation  1) Three minutes prior to laryngoscopy and endotracheal intubation - recorded as baseline
2. During laryngoscopy and endotracheal intubation
3. One minute after laryngoscopy and endotracheal intubation
4. Three minutes after laryngoscopy and endotracheal intubation
5. Five minutes after laryngoscopy and endotracheal intubation
6. Seven minutes laryngoscopy and endotracheal intubation
7. Nine minutes after laryngoscopy and endotracheal intubation  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Efficacy of Esmolol IV & Lidocaine IV in decreasing haemodynamic stress response during laryngoscopy and endotracheal intubation in cardiovascular surgeries is being studied. Objective is to study the Efficacy of Esmolol IV & Lidocaine IV in decreasing haemodynamic stress response during laryngoscopy and endotracheal intubation in cardiovascular surgeries.

 

INCLUSION CRITERIA

·         Patients willing to sign informed consent

·         Male or Female patients between 18 to 60 years of age

·         Patients belonging to American Society of Anaesthesiologists(ASA) physical status I & II

·         Patients posted for elective laparoscopic surgeries under general anaesthesia.

 

 

EXCLUSION CRITERIA

·         Patients unwilling to participate in study.

·         Patients with Body Mass Index > 29 Kg/m^2

·         Patients with cerebrovascular diseases, hepatic and/or renal diseases

·         Psychiatric patients

·         Pregnancy and lactating women

·         Patients belonging to American Society of Anaesthesiologists (ASA) III and above.

 

We will be conducting this study on 72 adults aged 18-60 years belonging to grade I &  II American Society of Anaesthesiologists classification who will undergo laparoscopic surgeries under general anaesthesia. They will be divided into 2 equal groups by chit method. Group E will receive Inj. Esmolol 2 mg/kg 3 minutes prior to intubation. Group L will receive Inj. Lidocaine 2 mg/kg 3 minutes prior to intubation. The intervention will be performed by Consultant Anaesthesiologist prior to intubation.

 

 Haemodynamic parameters are measured

 1. Three minutes Before administration of test drugs (baseline)

 2. After administration of test drugs

 3. At laryngoscopy & endotracheal intubation

4. After intubation at 1st, 3rd, 5th & 7th minutes.

 

Site of study: Dept of anaesthesiology, S.B.K.S. Medical Institute & Research centre, Sumandeep Vidyapeeth, Piparia, Waghodia, Vadodara, Gujarat

 

Study Design: Prospective Randomised consoled study

 Study Duration: The study will be initiated after obtaining permission from institutional ethical committee till the achievement of the sample size or 1 year after the approval from ethical committee (whichever is earlier)

 

Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percentage. As regard to numerical variables; tests like unpaired student-t test and/or ANNOVA will be used wherever appropriate for between-groups comparisons, while for categorical variables; chi-square test will be used. P value

 

Likely outcome: This prospective and comparative study will help us to compare the efficacy between  Esmolol and Lidocaine on haemodynamic stress response during laryngoscopy & endotracheal intubation in patients undergoing cardiovascular surgeries by having better outcome in haemodynamics.

 
Close