| CTRI Number |
CTRI/2023/05/052535 [Registered on: 11/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
To compare the efficacy of fentanyl and paracetamol magnesium combination in decreasing the pain during sternotomy in Coronary artery bypass grafting. |
|
Scientific Title of Study
|
Comparison between the efficacy of fentanyl and paracetamol-magnesium combination in attenuating hemodynamic response to sternotomy in patients undergoing coronary artery bypass grafting-a randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sivakamasundari V |
| Designation |
Resident,DNB anesthesia |
| Affiliation |
Kovai medical center and hospital |
| Address |
Dept of Anaesthesiology, OT complex-1, second floor,cancer center block,kovai medical center and hospital,Avinashi road,Indira nagar,civil aerodrome post,Coimbatore,Tamilnadu
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9442125936 |
| Fax |
|
| Email |
shivavetri712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kappian |
| Designation |
consultant anaesthestist |
| Affiliation |
kovai medical center and hospitals |
| Address |
Dept of Anaesthesiology, OT complex-1, second floor,cancer center block,kovai medical center and hospital,Avinashi road,Indira nagar,civil aerodrome post,Coimbatore,Tamilnadu
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9445807241 |
| Fax |
|
| Email |
kappianmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kappian |
| Designation |
consultant anaesthestist |
| Affiliation |
kovai medical center and hospitals |
| Address |
Dept of Anaesthesiology, OT complex-1, second floor,cancer center block,kovai medical center and hospital,Avinashi road,Indira nagar,civil aerodrome post,Coimbatore,Tamilnadu
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9445807241 |
| Fax |
|
| Email |
kappianmd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kovai medical center and hospital, coimbatore |
|
|
Primary Sponsor
|
| Name |
Kovai medical center and hospital |
| Address |
Avinashi road,peelamedu,coimbatore.
Pincode : 641014 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Amar Nandhakumar |
Kovai medical center and hospital |
HOD,Dept of Anaesthesiology, OT complex-1, second floor,cancer center block,kovai medical center and hospital,Avinashi road,Indira nagar,civil aerodrome post,Coimbatore,Tamilnadu.
Coimbatore
TAMIL NADU |
9486369403
amarailanto@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl |
Fentanyl is a potent synthetic opioid used in control group in this study.It significantly reduces the sympathetic response to sternotomy but has got side effects like delayed extubation,constipation and drowsiness. |
| Intervention |
paracetamol and magnesium |
Paracetamol being a nonsteroidal anti inflammatory drug has a well established safety and analgesic profile.It decreases the perioperative opioid requirements. Magnesium has antiarrythmic and antihypertensive properties.Paracetamol and magnesium when used together can significantly reduce the sympathetic response to sternotomy.In this study we are mainly comparing hemodynamic responses to sternotomy for every minute for 5 minutes following sternotomy.We also compare the time taken for extubation following the end of surgery and postoperative opioid requirements in study and control group |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ejection fraction>50%
ASA grade 3 and 4 |
|
| ExclusionCriteria |
| Details |
1.patients who are not willing
2.severe left ventricular dysfunction
3.patients who are on ionotropes
4.patients on IABP
5.patients with conduction blocks
6.patients requiring valvular replacements |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of fentanyl and paracetamol-magnesium combination in attenuating increase in BP and heart rate in patients undergoing Coronary artery bypass grafting |
From the time of induction to 5 minutes following sternotomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time to extubation, postoperative pain intensity and analgesia requirements |
First 24 hours of postoperative period |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, double-blind, parallel group, single centre trial comparing the efficacy of fentanyl 2mcg/ kg and paracetamol 1gm-magnesium 1gm combination in attenuating increase in BP and heart rate as a response to sternotomy in patients undergoing elective Coronary artery bypass grafting. This study also aims to compare the time taken for extubation,postoperative pain intensity and analgesia requirements in first 24 hours of postoperative period. |