| CTRI Number |
CTRI/2021/09/036550 [Registered on: 15/09/2021] Trial Registered Prospectively |
| Last Modified On: |
24/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effects of cisatracurium and atracurium on levels of tryptase, Ig E and absolute eosinophil count in adult patients undergoing general anesthesia for elective surgery. |
|
Scientific Title of Study
|
Comparison of effects of cisatracurium and atracurium upon Tryptase, IgE levels and Absolute eosinophil counts in adult patients undergoing general anesthesia for elective surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TP(MD/MS)930/2020)/IEC/ABVIMS/RMLH/317 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Kumari |
| Designation |
Postgraduate student |
| Affiliation |
ABVIMS and Dr RMLH New Delhi |
| Address |
ABVIMS and Dr RMLH New Delhi, 110001. Department of anesthesia.
ABVIMS and Dr RMLH New Delhi, 110001. Department of anesthesia.
New Delhi
DELHI
110001
India |
| Phone |
08826803515 |
| Fax |
|
| Email |
neha11j94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar Nagpal |
| Designation |
Professor and Consultant |
| Affiliation |
ABVIMS and Dr RMLH, New Delhi |
| Address |
Department of Anesthesia, ABVIMS and Dr RMLH, New Delhi
Department of Anesthesia, ABVIMS and Dr RMLH, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
09968304240 |
| Fax |
|
| Email |
nagpalvijaykumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kumar Nagpal |
| Designation |
Professor and Consultant |
| Affiliation |
ABVIMS and Dr RMLH, New Delhi |
| Address |
Department of Anesthesia, ABVIMS and Dr RMLH, New Delhi
Department of Anesthesia, ABVIMS and Dr RMLH, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
09968304240 |
| Fax |
|
| Email |
nagpalvijaykumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr RMLH New Delhi |
|
|
Primary Sponsor
|
| Name |
ABVlMS and Dr RML hospital |
| Address |
Baba Karak Singh Road, ABVIMS and Dr RMLH, New Delhi 110001 |
| 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 |
| Neha Kumari |
ABVIMS and Dr RML Hospital,New Delhi, 110001. |
Department of Anesthesia and Department of Biochemistry .
New Delhi
DELHI |
8826803515
neha11j94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Atracurium Besylate |
Blood samples will be taken from patients at following times:
i. before induction,
ii.one and two hours after giving first dose of study drug (Inj Atracurium at a dose of 0.25 mg/kg in group 2) and
iii. at the time if any side effects occur to check its effects on serum tryptase levels, IgE levels and absolute eosinophil count due to the study drug. |
| Comparator Agent |
Inj Cisatracurium besylate |
Blood samples will be taken from patients at folllowing times:
i. before induction ,
ii.one and two hours after giving first dose of study drug (Inj cisatracurium at a dose of 0.03 mg/kg intravenous in group 1) and
iii. at the time if any side effects occur
to check its effect on serum tryptase levels, IgE levels and absolute eosinophil count due to the study drug. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Consenting adult patients with ASA Grade 1/2
and modified Mallampati grade 1/2 |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway.
Patients with peripheral neuropathy, diabetes mellitus, neuromuscular disorders and myopathies.
Patients on antibiotics (e.g., aminoglycosides, tetracyclins, bacitracin, lincomycin, clindamycin, colistin).
Patients on drugs like Magnesium sulphate, lithium, procainamide and quinidine.
Patients with history of atopy and asthma.
Patients with known allergy to any of the drugs involved in study.
pregnant patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients tryptase levels,IgE levels, absolute eosinophil count, hemodynamic parameters (heart rate and SBP/DBP), cilinical side effects ( flushing of skin, rashes, hypotension, tachycardia, bronchospasm, anaphylaxis, arrhythmias) |
Blood samples will be taken before induction , one and two hour after giving first dose of study drug and additional sample if and when any side effects occurs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/10/2021 |
| Date of Study Completion (India) |
31/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a randomized prospective observational study in which comparison will be done on effects of cisatracurium and atracurium upon trypase levels , Ig E levels and absolute eosinophil counts in adult patients undergoing general anesthesia for elective surgery in Dr RML hospital New Delhi . The outcome measures will be tryptase levels, IgE levels, absolute eosinophil count , hemodynamic parameters and clinical side effects profile of the patients before induction, one and two hours after giving first dose of study drug and at the time of any side effects if any. |