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CTRI Number  CTRI/2025/02/080438 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 11/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the effects of Fentanyl-Clonidine vs Fentanyl-Lidocaine on haemodynamics during intubation in cardiovascular surgeries  
Scientific Title of Study   Fentanyl-clonidine & fentanyl-lidocaine on attenuation of hemodynamic stress response to laryngoscopy and tracheal intubation in cardiovascular surgery - A comparative study  
Trial Acronym  NILL 
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. Bhikhiben Kanjibhai Medical Institute and research centre 
Address  Dept. of Anesthesiology, General O.T. Complex, 2nd floor, Dhiraj Hospital, Smt. Bhikhiben Kanjibhai Medical Institute and research centre,Piparia, Waghodiya.

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. Bhikhiben Kanjibhai Medical Institute and research centre 
Address  Dept. of Anesthesiology, General O.T. Complex, 2nd floor, Dhiraj Hospital, Smt. Bhikhiben Kanjibhai Medical Institute and research centre,Piparia, Waghodiya.

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. Bhikhiben Kanjibhai Medical Institute and research centre 
Address  Dept. of Anesthesiology, General O.T. Complex, 2nd floor, Dhiraj Hospital, Smt. Bhikhiben Kanjibhai Medical Institute and research centre,Piparia, Waghodiya.

Vadodara
GUJARAT
391760
India 
Phone  7058308703  
Fax    
Email  drkalpeshpatil86@gmail.com  
 
Source of Monetary or Material Support  
Smt. Bhikhiben Kanjibhai Shah Medical Institute and research centre, Pipariya, Waghodia, Vadodara, Gujarat, India-391760 
 
Primary Sponsor  
Name  Smt. Bhikhiben Kanjibhai Shah Medical Institute and research centre 
Address  Pipariya, Waghodia, Vadodara, Gujarat, India-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  Smt. Bhikhiben Kanjibhai Medical Institute and research centre  Dept. Of Anaesthesiology, CTVS & General OT Complex, 2nd Floor, Dhiraj Hospital, Smt. Bhikhiben Kanjibhai Medical Institute and research centre, Sumandeep Vidyapeeth, Piparia, Waghodiya.
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: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj. Fentanyl 2 mcg/kg & Inj. Clonidine 2 mcg/kg  Inj. Fentanyl 2 mcg/kg & Inj. Clonidine 2 mcg/kg Given 3 minutes prior to laryngoscopy & Endotracheal Intubation 
Comparator Agent  Inj. Fentanyl 2 mcg/kg & Inj. Lidocaine 1.5 mg/kg   Inj. Fentanyl 2 mcg/kg & Inj. Lidocaine 1.5 mg/kg Given 3 minutes before laryngoscopy and endotracheal intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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, & III
4) Patients posted for elective cardiovascular surgeries under general anaesthesia.
5) Patients with ejection fraction more than or equal to 40%
 
 
ExclusionCriteria 
Details  1) Patients unwilling to participate in the study
2) Patients with Body Mass Index more 29 kg per meter 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) 4 and above.
7) Patients with ejection fraction less than 40%
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study Haemodynamic response during Laryngoscopy & endotracheal intubation  1) At baseline
2) After test drug administration
3) After Induction
4) At Laryngoscopy and Endotracheal intubation
5) After intubation at 1st, 3rd, 5th and 7th minutes  
 
Secondary Outcome  
Outcome  TimePoints 
To study Sedation Score after extubation or any side effects  1) Immediately after extubation
2) Every 5 minutes after extubation till the completion of 30 minutes
3) Then every 30 minutes till the completion of 2 hours. 
 
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)   25/02/2025 
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="6"
Days="0" 
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 Fentanyl-Clonidine & Fentanyl-Lidocaine in decreasing haemodynamic stress response during laryngoscopy and endotracheal intubation in cardiovascular surgeries  is being studied. 

 

Objective is to study the Efficacy of Fentanyl-Clonidine & Fentanyl-Lidocaine 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, & III

·       Patients posted for elective cardiovascular surgeries under general anaesthesia.

·       Patients with ejection fraction more than or equal to 40%

 

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) 4 and above.

·       Patients with ejection fraction less than 40%.

 

We will be conducting this study on 72 adults aged 18-60 years belonging to grade I, II & III American Society of Anaesthesiologists classification who will undergo elective cardiovascular surgeries under general anaesthesia. They will be divided into 2 equal groups by chit method.

 

Group FC will receive Inj. Fentanyl 2 mcg/kg & Inj. Clonidine 2 mcg/kg 3 minutes prior to intubation.

Group FL will receive Inj. Fentanyl 2 mcg/kg & Inj. Lidocaine 1.5 mg/kg 3 minutes prior to intubation.



The intervention will be performed by Consultant Anaesthesiologist prior to intubation. 

 

Haemodynamic parameters are measured 

1.     Before administration of test drugs (baseline) 

2.     After administration of test drugs

3.      After induction

4.     At laryngoscopy & endotracheal intubation 

5.     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 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 <0.05 will be considered statistically significant. between-groups comparisons, while for categorical variables; chi-square test will be used. P value <0.05 will be considered statistically significant.

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

 
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