| CTRI Number |
CTRI/2019/01/017084 [Registered on: 15/01/2019] Trial Registered Prospectively |
| Last Modified On: |
14/01/2019 |
| 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
|
COMPARISON OF ONSET AND RECOVERY FROM FIRST NEUROMUSCULAR BLOCKADE BETWEEN CISATRACURIUM AND ATRACURIUM |
|
Scientific Title of Study
|
ATRACURIUM VERSUS CISATRACURIUM: ONSET AND RECOVERY FROM FIRST NEUROMUSCULAR BLOCKADE IN ADULT SURGICAL PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Palak R Bohra |
| Designation |
Junior resident |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 7 ,RESIDENT GIRLS HOSTEL, MGM MEDICAL COLLEGE AND HOSPITAL, N-6 CIDCO, AURANGABAD
MGM MEDICAL COLLEGE AND HOSPITAL , N-6 CIDCO , AURANGABAD, 431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8698032592 |
| Fax |
|
| Email |
palak.leo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SANHITA J KULKARNI |
| Designation |
Associate Professor |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPITAL |
| Address |
Dept. of Anaesthesia, MGM MEDICAL COLLEGE AND HOSPITAL , N-6 CIDCO, AURANGABAD
MGM MEDICAL COLLEGE AND HOSPITAL , N-6 CIDCO , AURANGABAD, 431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9881300645 |
| Fax |
|
| Email |
drsanhitakulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Palak R Bohra |
| Designation |
Junior resident |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 7, RESIDENT GIRLS HOSTEL, MGM MEDICAL COLLEGE AND HOSPITAL, N-6 CIDCO, AURANGABAD
MGM MEDICAL COLLEGE AND HOSPITAL , N-6 CIDCO , AURANGABAD, 431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8698032592 |
| Fax |
|
| Email |
palak.leo@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM MEDICAL COLLEGE AND HOSPITAL, N-6 CIDCO, AURANGABAD, 431003 |
|
|
Primary Sponsor
|
| Name |
MGM MEDICAL COLLEGE AND HOSPITAL |
| Address |
MGM MEDICAL COLLEGE AND HOSPITAL , N-6 CIDCO , AURANGABAD, 431001 |
| 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 PALAK R BOHRA |
MGM MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIA, 2nd FLOOR
Aurangabad
MAHARASHTRA |
8698032592
palak.leo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ADULT PATIENTS UNDERGOING SURGICAL PROCEDURES |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ATRACURIUM |
DOSE: 0.6MG/KG IV
NEUROMUSCULAR BLOCKING AGENT |
| Intervention |
CIS-ATRACURIUM |
DOSE: 0.15MG/KG IV
NEURMUSCULAR BLOCKING AGENT |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS UNDERGOING ANY SURGICAL PROCEDURE UNDER GENERAL ANAESTHESIA REQUIRING NEUROMUSCULAR BLOCKADE |
|
| ExclusionCriteria |
| Details |
ANTICIPATED DIFFICULT INTUBATION
RISK OF ASPIRATION
ASA GRADE 3 AND ABOVE
HYPERSENSITVITY TO NEUROMUSCULAR BLOCKING AGENTS
PATIENTS WITH HEPATIC OR RENAL DISEASE
BMI MORE THAN 30 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
ONSET OF ACTION
HAEMODYNAMIC STABILITY
RECOVERY FROM FIRST LOADING DOSE OF CIS-ATRACURIUM AND ATRACURIUM |
ONSET OF ACTION
HAEMODYNAMIC STABILITY
RECOVERY FROM FIRST LOADING DOSE OF CIS-ATRACURIUM AND ATRACURIUM |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
INTUBATING CONDITIONS
ADVERSE REACTIONS |
5 MINUTES |
|
|
Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
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)
|
01/02/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Atracurium and Cisatracurium are two non depolarizing
NMB agents with intermediate duration of action belonging to benzylisoquinolinium
group.
Atracurium is metabolized by Hofmann degradation and
alkaline ester hydrolysis in the plasma and elsewhere in the body. It is
associated with production of tertiary metabolite laudanosine which has slow
renal elimination and crosses blood brain barrier.
Atracurium is associated with dose as well as speed of
injection dependent histamine release which presents as transient hypotension,
tachycardia and facial flushing.
Cisatracurium is a purified form of one of the 10 stereoisomers of atracurium which is
approximately 3 times more potent than atracurium and unlike the parent
compound, is not associated with dose-dependent histamine release in humans.
Cisatracurium undergoes Hofmann elimination but not
hydrolysis by plasma esterases. Laudanosine levels are much lower compared to
atracurium
.
The primary objective of this study is to compare the
onset of neuromuscular blockade and recovery from the first loading dose
between the two non-depolarizing NMBD, cisatracurium and atracurium in adult
patients undergoing surgical procedures under general anaesthesia.
The secondary objective is to observe the haemodynamic
stability and adverse effects in relation to both the NMBDs. |