| CTRI Number |
CTRI/2024/04/065071 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
T o compare effects of sevoflurane and desflurane in patients undergoing open heart surgery |
|
Scientific Title of Study
|
A randomized comparative study for effects of sevoflurane vs desflurane on myocardial protection perioperative haemodynamics and organ functions in patients undergoing open heart surgery in department of anaesthesia at SMS Hospital Jaipur |
| 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 Anjum Saiyed |
| Designation |
Senior Professor |
| Affiliation |
|
| Address |
Dept of anaesthesia room no 20 second floor dhanvantari complex SMS medical college and attached hospitals Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
dranjumsaiyed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjum Saiyed |
| Designation |
Senior Professor |
| Affiliation |
|
| Address |
Dept of anaesthesia room no 20 dhanvantari complex SMS medical college and attached hospitals Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
dranjumsaiyed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjum Saiyed |
| Designation |
Senior Professor |
| Affiliation |
|
| Address |
Dept of anaesthesia room no 20 dhanvantari complex second floor SMS medical college and attached hospitals Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
dranjumsaiyed@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT of Anaesthesia SMS medical college and hospital Jaipur rajasthan India 302004 |
|
|
Primary Sponsor
|
| Name |
Dr Anjum Saiyed |
| Address |
Dept of anaesthesia SMS Medical college and attached hospital Jaipur rajasthan India pin 302004 |
| Type of Sponsor |
Government 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 Ali Zeeshan Khan |
SMS medical college and attached hospitals |
Second floor dhanvantari building JLN MARG JAIPUR rajasthan India pin 302004
Jaipur
RAJASTHAN |
9079193797
alizeeshan2512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I43||Cardiomyopathy in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Desflurane |
Haemodynamics myocardial protection |
| Intervention |
Randomized comparative study of sevoflurane vs desflurane for effects in patients undergoing open heart surgery |
Myocardial protection. Haemodynamics and organ functions |
| Comparator Agent |
Sevoflurane |
Haemodynamics myocardial protection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing planned cardiac surgery on cpb
Written informed consent for the study
Patients age 18 to 75 years of either sexist
ASA GRADE II AND III
PATIENTS BODY WEIGHT 40 TO 70 KGS
BMI MORE THAN 30 |
|
| ExclusionCriteria |
| Details |
Patient should not be a part of any other study
Non cooperative patient
Emergency surgery
History of endocrine metabolic neurological and psycotic disorders
Patients with serious haemostatic disorders
Previous unusual response to the study group |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean duration of postoperative mechanical ventilation at the ICU
Mean changes in serum troponin and cpk mb levels at different time intervals
Mean of haemodynamics parameter HR SBP DBP MAP CVP
Mean of serum glucose urea creatinine SGOT SGPT bilirubin hematocrit
Mean CACUS Score
Proportion of side effects any |
Base time or zero min 30 minute 60 min 90 min 120 min 150 min 180 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamics myocardial protection |
Baseline 30 60 90 120 150 180 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/04/2024 |
| 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
|
Patients posted for cardiac surgeries on CPB under GA after fulfilling inclusion criterion will be divided into two groups each 30 after randomisation by sealed enveloped method and heamodynamic variables will be noted and data ll be collected and statistical analysis ll be done. |