| CTRI Number |
CTRI/2024/01/061942 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Two Drugs For Avoidance Of Rise In Heart Rate And Blood Pressure While Securing The Airway At Start Of Anaesthesia |
|
Scientific Title of Study
|
Comparative Study Of Clonidine & Esmolol In Attenuation Of Hemodynamic Stress Response To Endotracheal Intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhashis Saha |
| Designation |
Post Graduate Trainee |
| Affiliation |
KPC Medical College & Hospital |
| Address |
Department Of Anaesthesiology, Room No 230 KPC Medical College & Hospital, Jadavpur, Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
9038963053 |
| Fax |
|
| Email |
subhashissaha5009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Debjani Gupta |
| Designation |
Associate Professor |
| Affiliation |
KPC Medical College & Hospital |
| Address |
Department Of Anaesthesiology, Room No 233 KPC Medical College & Hospital, Jadavpur, Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830071577 |
| Fax |
|
| Email |
debjani258@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Debjani Gupta |
| Designation |
Associate Professor |
| Affiliation |
KPC Medical College & Hospital |
| Address |
Department Of Anaesthesiology, Room No 233 KPC Medical College & Hospital, Jadavpur, Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830071577 |
| Fax |
|
| Email |
debjani258@gmail.com |
|
|
Source of Monetary or Material Support
|
| KPC Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
KPC Medical College and Hospital |
| Address |
1F, Raja Subodh Chandra Mallick Road, Jadavpur, Kolkata-700032, West Bengal |
| 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 Debjani Gupta |
KPC Medical College & Hospital |
Department Of Anaesthesiology, Room No. 232,
1F, Raja Subodh Chandra Mallick Road, Jadavpur, Kolkata-700032 West Bengal
Kolkata
WEST BENGAL |
9830071577
debjani258@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KPC Medical College & Hospital, Jadavpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clonidine |
30 patients will be given intravenous infusion Clonidine, 2 mcg/kg, diluted in 20 ml of normal saline, slowly over 10 minutes before induction |
| Intervention |
Esmolol |
30 patients will be given intravenous Esmolol, 1.5 mg/kg, as a loading dose, over a period of 5 minutes before induction |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients undergoing elective laparoscopic surgery
2. American Society Of Anesthesiologists Grade 1
3. Patients giving Informed Written, Valid consent |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years and more than 45 years
2. Known allergy to anaesthetic agents
3. History of substance abuse and current opioid use
4. Anticipated difficult intubation
5. Duration of laryngoscopy more than 15 seconds
6. Baseline pulse less than 60 beats per minute
7. Baseline systolic blood pressure less than 100 mm Hg
8. Surgery time exceeding 2 hours
9. Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary aim of the study is to compare the efficacy of Clonidine and Esmolol in attenuation of hemodynamic stress response due to laryngoscopy and endotracheal intubation. |
Rate Pressure Product (RPP) will be recorded just after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary aim of the study is to compare the efficacy of Clonidine & Esmolol in attenuation of hemodynamic stress response during pneumoperitoneum. |
Rate Pressure Product (RPP) will be recorded 5 minutes after pneumoperitoneum |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
12/02/2024 |
| 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="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
|
Laryngoscopy and endotracheal intubation violate the patient’s protective airway reflexes and invariably cause hemodynamic changes associated with increased heart rate, increased blood pressure and occasional disturbance in cardiac rhythm. Effective attenuation of the sympathoadrenal stress response is an important goal in anesthesiology. Clonidine is an alpha 2 receptor agonist, which acts by decreasing central sympathetic outflow, increasing the parasympathetic tone and by decreasing circulating noradrenaline concentration. Esmolol is a short-acting cardioselective beta blocker, which reduces heart rate, systolic blood pressure, ejection fraction and cardiac index but it maintains coronary perfusion pressure. In this study an attempt will be made to observe, assess and compare the efficacy of Clonidine and Esmolol, in attenuating the haemodynamic response following laryngoscopy and endotracheal intubation |