| 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
|
|
|
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
|
|
|
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. |