| CTRI Number |
CTRI/2024/02/062258 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Clinical trial to study the effects of two drugs cisatracurium and rocuronium in paediatric patients undergoing routine surgeries under general anaesthesia |
|
Scientific Title of Study
|
A Comparative study to evaluate the efficacy of cisatracurium and rocuronium for endotracheal intubation in paediatric Patients : A prospective randomized study |
| 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 R. Deepak |
| Designation |
Junior resident 2 |
| Affiliation |
Gajra raja medical College |
| Address |
Department of Anaesthesiology, gajra raja medical college,Gwalior, Madhya Pradesh, 474009 ,INDIA
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
6381463114 |
| Fax |
|
| Email |
deepakranganadhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema shende |
| Designation |
Associate professor |
| Affiliation |
Gajra raja medical College |
| Address |
Department of Anaesthesiology, gajra raja medical college,Gwalior, Madhya pradesh,474009, INDIA
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
7566439701 |
| Fax |
|
| Email |
drseema26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R. Deepak |
| Designation |
Junior resident 2 |
| Affiliation |
Gajra raja medical College |
| Address |
Department of Anaesthesiology, gajra raja medical college,Gwalior, Madhya pradesh, 474009 ,INDIA
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
6381463114 |
| Fax |
|
| Email |
deepakranganadhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| GRMC,Department of Anaesthesiology Gwalior, mp,474009 |
|
|
Primary Sponsor
|
| Name |
Dr R Deepak |
| Address |
Department of Anaesthesiology, gajra raja medical college,Gwalior, Madhya Pradesh 474009 India |
| Type of Sponsor |
Other [Self] |
|
|
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 R Deepak |
Gajra raja medical collage |
Department of Anaesthesiology,gajra raja medical college,Gwalior,Madhya Pradesh 474009,India
Gwalior
MADHYA PRADESH |
6381463114
deepakranganadhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committe,gajra raja medical college,gwalior |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cisatracurium |
cisatracurium 0.15mg/kg given intravenously ,endotracheal intubation was done after 3 minutes of drug administration in paediatric patients undergoing elective surgeries under general anaesthesia |
| Comparator Agent |
Rocuronium |
rocuronium 0.6 mg/kg given intravenously , endotracheal intubation was done after 3 min of drug administration in paediatric patients undergoing elective surgery under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing elective surgical procedures under general anaesthesia between 2 to 12 years of age and between 10 kg to 40 kg body weight |
|
| ExclusionCriteria |
| Details |
patients refusal,ASA grade 3 and 4 ,age below 2 years and above 12 years,weight below 10 kg and above 40 kg,patient with disorders of cardiovascular,hepatic,renal or neuromuscular system and epilepsy,pt with airway problems suggestive of difficult intubation,patients with know history of drug allergy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| rocuronium has rapid onset and produces excellent to good intubating conditions than cisatracurium |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no adverse effects noted with both cisatracurium and rocuronium |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/02/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a prospective randomized study to compare the efficacy and safety of cisatracurium 0.15mg/kg and rocuronium 0.6mg/kg for endotracheal intubation in paediatric patients undergoing elective surgery under general anaesthesia ,study was conducted in 50 paediatric patients between 2 to 12 years of age with body weight between 10kg to 40 kg .primary outcome of the study is to show that rocuronium provides better intubating conditions than cisatracurium. And also to show that both these drugs are safe to use in paediatric patients |