| 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
|
|
|
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
|
|
|
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. |